Preventing formation of blood clots due to atrial fibrillation, a cardiac arrhythmia that first occurred after coronary bypass surgery, with the help of anticoagulant medications.

2024-515924-35-00 Protocol PACeS, final 3.0 Therapeutic use (Phase IV) Ongoing, recruiting

Start 16 Jan 2023 · Status Ongoing, recruiting · 1 EU/EEA countries · 16 sites · Protocol PACeS, final 3.0

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)
Status Ongoing, recruiting
Participants planned 3,200
Countries 1
Sites 16

New-Onset Post-Operative Atrial Fibrillation after CABG

The primary objective is the effectiveness (prevention of thromboembolic events) and safety (major bleeding) of adding oral anticoagulation (OAC) to background antiplatelet therapy in patients who develop new-onset POAF after isolated CABG surgery.

Key facts

Sponsor
Icahn School Of Medicine At Mount Sinai
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Cardiovascular Diseases [C14]
Trial duration
16 Jan 2023 → ongoing
Decision date (initial)
2024-07-29
Transition trial
Yes
Low-intervention
Yes
Rare-disease indication
No
Vulnerable population
No
Funding sources
US NIH Grant # 2U01HL088942-12

External identifiers

EU CT number
2024-515924-35-00
EudraCT number
2021-005022-18
ClinicalTrials.gov
NCT04045665

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

The primary objective is the effectiveness (prevention of thromboembolic events) and safety (major bleeding) of adding oral anticoagulation (OAC) to background antiplatelet therapy in patients who develop new-onset POAF after isolated CABG surgery.

Secondary objectives 1

  1. The secondary objective of this trial is to evaluate the burden of atrial fibrillation 30 days post discharge using continuous monitoring devices in patients who have developed new-onset POAF after CABG. This aim will be addressed in an ancillary study. Currently, this ancillary study will not be performed at the European trial sites.

Conditions and MedDRA coding

New-Onset Post-Operative Atrial Fibrillation after CABG

VersionLevelCodeTermSystem organ class
20.0 PT 10003658 Atrial fibrillation 100000004849

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

  1. Patients of age ≥18 years who undergo isolated CABG for coronary artery disease
  2. POAF that persists for >60 minutes or is recurrent (more than one episode) within 7 days after the index CABG

Exclusion criteria 21

  1. Clinical history of either permanent, persistent or paroxysmal atrial fibrillation
  2. Any pre-existing clinical indication for long-term OAC
  3. Any absolute contraindication to OAC
  4. Planned use of post-operative dual antiplatelet therapy (DAPT)
  5. Cardiogenic shock
  6. Major perioperative complication occurring between CABG and randomization
  7. Concomitant mitral valve annuloplasty during CABG
  8. Concomitant valve surgery during CABG or prior valve surgery (including aortic, mitral, tricuspid or pulmonary)
  9. Concomitant mitral valve annuloplasty during CABG
  10. Concomitant carotid artery endarterectomy during CABG
  11. Concomitant aortic root replacement during CABG
  12. Concomitant surgery for AF during CABG
  13. Liver cirrhosis or Child-Pugh Class C chronic liver disease
  14. Pharmacologic therapy with an investigational drug or device within 30-days prior to randomization or plan to enroll patient in an investigational drug or device trial during participation in this trial
  15. Pregnancy at the time of randomization
  16. Unable or unwilling to provide informed consent
  17. Unable or unwilling to comply wit the study treatment and followup
  18. Existence of underlying disease that limits life expectancy to less than one year
  19. Women of childbearing potential (within two years after the last spontaneous menstruation) without effective contraceptive measures (Implanon, injections, oral contraceptives, intrauterine devices, vasectomized partner) during study participation. (Participants using hormone-based preparations must be informed about possible interactions with the study medication)
  20. Participation in other interventional studies
  21. Patients under legal supervision or guardianship

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

  1. Primary effectiveness endpoint: composite of death, ischemic stroke, transient ischemic attack (TIA), myocardial infarction (MI), systemic arterial thromboembolism or venous thromboembolism (VTE) (deep venous thrombosis (DVT) and/or pulmonary embolism (PE))
  2. Primary safety endpoint: Bleeding Academic Research Consortium (BARC) type 3 or 5

Secondary endpoints 11

  1. Composite of death, ischemic stroke, TIA, MI, or systemic arterial thromboembolism
  2. Net clinical benefit (NCB)
  3. Incidence of the primary effectiveness and safety endpoints at 180 days after randomization
  4. Individual components of the primary effectiveness and safety endpoints at 90 d and 180 days after randomization
  5. Cardiovascular and non-cardiovascular mortality at 90 and180 days after randomization
  6. Incidence of BARC 2 bleeding at 90 and 180 days after randomization
  7. Cardiac arrhythmias including recurrent symptomatic or asymptomatic AF requiring medical attention at 90 and 180 days after randomization
  8. Length of stay of index hospitalization
  9. Number and reasons for readmissions at 90 and 180 days after rendomization
  10. Hospital resource utilization at 180 days after surgey
  11. Patients' convenience and satisfaction survey utilizing the Perception of Anticoagulation Treatment Questionnaire (PACT-Q2) at 90 days after randomization

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 24

Eliquis 2.5 mg film-coated tablets

PRD2351235 · Product

Active substance
Apixaban
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
60 mg milligram(s)
Max total dose
5400 mg milligram(s)
Max treatment duration
90 Day(s)
Authorisation status
Authorised
ATC code
B01AF02 — -
Marketing authorisation
EU/1/11/691/001
MA holder
BRISTOL-MYERS SQUIBB/PFIZER EEIG
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Eliquis 2.5 mg film-coated tablets

PRD2351318 · Product

Active substance
Apixaban
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
60 mg milligram(s)
Max total dose
5400 mg milligram(s)
Max treatment duration
90 Day(s)
Authorisation status
Authorised
ATC code
B01AF02 — -
Marketing authorisation
EU/1/11/691/013
MA holder
BRISTOL-MYERS SQUIBB/PFIZER EEIG
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Eliquis 2.5 mg film-coated tablets

PRD2351250 · Product

Active substance
Apixaban
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
60 mg milligram(s)
Max total dose
5400 mg milligram(s)
Max treatment duration
90 Day(s)
Authorisation status
Authorised
ATC code
B01AF02 — -
Marketing authorisation
EU/1/11/691/003
MA holder
BRISTOL-MYERS SQUIBB/PFIZER EEIG
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Eliquis 2.5 mg film-coated tablets

PRD2351265 · Product

Active substance
Apixaban
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
60 mg milligram(s)
Max total dose
5400 mg milligram(s)
Max treatment duration
90 Day(s)
Authorisation status
Authorised
ATC code
B01AF02 — -
Marketing authorisation
EU/1/11/691/002
MA holder
BRISTOL-MYERS SQUIBB/PFIZER EEIG
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Eliquis 2.5 mg film-coated tablets

PRD2351236 · Product

Active substance
Apixaban
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
60 mg milligram(s)
Max total dose
5400 mg milligram(s)
Max treatment duration
90 Day(s)
Authorisation status
Authorised
ATC code
B01AF02 — -
Marketing authorisation
EU/1/11/691/004
MA holder
BRISTOL-MYERS SQUIBB/PFIZER EEIG
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Eliquis 2.5 mg film-coated tablets

PRD2351251 · Product

Active substance
Apixaban
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
60 mg milligram(s)
Max total dose
5400 mg milligram(s)
Max treatment duration
90 Day(s)
Authorisation status
Authorised
ATC code
B01AF02 — -
Marketing authorisation
EU/1/11/691/005
MA holder
BRISTOL-MYERS SQUIBB/PFIZER EEIG
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Marcumar 3 mg Tabletten

PRD537009 · Product

Active substance
Phenprocoumon
Pharmaceutical form
TABLET
Route of administration
ORAL USE
Max daily dose
9 mg milligram(s)
Max total dose
810 mg milligram(s)
Max treatment duration
90 Day(s)
Authorisation status
Authorised
ATC code
B01AA04 — PHENPROCOUMON
Marketing authorisation
6037262.00.00
MA holder
VIATRIS HEALTHCARE GMBH
MA country
Germany
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Pradaxa 75 mg hard capsules

PRD797702 · Product

Active substance
Dabigatran Etexilate
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL USE
Max daily dose
600 mg milligram(s)
Max total dose
54000 mg milligram(s)
Max treatment duration
90 Day(s)
Authorisation status
Authorised
ATC code
B01AE07 — -
Marketing authorisation
EU/1/08/442/002
MA holder
BOEHRINGER INGELHEIM INTERNATIONAL GMBH
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Pradaxa 75 mg hard capsules

PRD289918 · Product

Active substance
Dabigatran Etexilate
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL USE
Max daily dose
600 mg milligram(s)
Max total dose
54000 mg milligram(s)
Max treatment duration
90 Day(s)
Authorisation status
Authorised
ATC code
B01AE07 — -
Marketing authorisation
EU/1/08/442/001
MA holder
BOEHRINGER INGELHEIM INTERNATIONAL GMBH
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Pradaxa 75 mg hard capsules

PRD290366 · Product

Active substance
Dabigatran Etexilate
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL USE
Max daily dose
600 mg milligram(s)
Max total dose
54000 mg milligram(s)
Max treatment duration
90 Day(s)
Authorisation status
Authorised
ATC code
B01AE07 — -
Marketing authorisation
EU/1/08/442/004
MA holder
BOEHRINGER INGELHEIM INTERNATIONAL GMBH
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Pradaxa 75 mg hard capsules

PRD290224 · Product

Active substance
Dabigatran Etexilate
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL USE
Max daily dose
600 mg milligram(s)
Max total dose
54000 mg milligram(s)
Max treatment duration
90 Day(s)
Authorisation status
Authorised
ATC code
B01AE07 — -
Marketing authorisation
EU/1/08/442/003
MA holder
BOEHRINGER INGELHEIM INTERNATIONAL GMBH
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Pradaxa 75 mg hard capsules

PRD1946591 · Product

Active substance
Dabigatran Etexilate
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL USE
Max daily dose
600 mg milligram(s)
Max total dose
54000 mg milligram(s)
Max treatment duration
90 Day(s)
Authorisation status
Authorised
ATC code
B01AE07 — -
Marketing authorisation
EU/1/08/442/017
MA holder
BOEHRINGER INGELHEIM INTERNATIONAL GMBH
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Xarelto 10 mg film-coated tablets

PRD3003287 · Product

Active substance
Rivaroxaban
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
30 mg milligram(s)
Max total dose
2700 mg milligram(s)
Max treatment duration
90 Day(s)
Authorisation status
Authorised
ATC code
B01AF01 — -
Marketing authorisation
EU/1/08/472/001
MA holder
BAYER AG
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Xarelto 10 mg film-coated tablets

PRD3003296 · Product

Active substance
Rivaroxaban
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
30 mg milligram(s)
Max total dose
2700 mg milligram(s)
Max treatment duration
90 Day(s)
Authorisation status
Authorised
ATC code
B01AF01 — -
Marketing authorisation
EU/1/08/472/005
MA holder
BAYER AG
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Xarelto 10 mg film-coated tablets

PRD3003291 · Product

Active substance
Rivaroxaban
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
30 mg milligram(s)
Max total dose
2700 mg milligram(s)
Max treatment duration
90 Day(s)
Authorisation status
Authorised
ATC code
B01AF01 — -
Marketing authorisation
EU/1/08/472/002
MA holder
BAYER AG
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Xarelto 10 mg film-coated tablets

PRD3003303 · Product

Active substance
Rivaroxaban
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
30 mg milligram(s)
Max total dose
2700 mg milligram(s)
Max treatment duration
90 Day(s)
Authorisation status
Authorised
ATC code
B01AF01 — -
Marketing authorisation
EU/1/08/472/010
MA holder
BAYER AG
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Xarelto 10 mg film-coated tablets

PRD3003290 · Product

Active substance
Rivaroxaban
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
30 mg milligram(s)
Max total dose
2700 mg milligram(s)
Max treatment duration
90 Day(s)
Authorisation status
Authorised
ATC code
B01AF01 — -
Marketing authorisation
EU/1/08/472/004
MA holder
BAYER AG
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Xarelto 10 mg film-coated tablets

PRD3003299 · Product

Active substance
Rivaroxaban
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
30 mg milligram(s)
Max total dose
2700 mg milligram(s)
Max treatment duration
90 Day(s)
Authorisation status
Authorised
ATC code
B01AF01 — -
Marketing authorisation
EU/1/08/472/008
MA holder
BAYER AG
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Xarelto 10 mg film-coated tablets

PRD3003298 · Product

Active substance
Rivaroxaban
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
30 mg milligram(s)
Max total dose
2700 mg milligram(s)
Max treatment duration
90 Day(s)
Authorisation status
Authorised
ATC code
B01AF01 — -
Marketing authorisation
EU/1/08/472/007
MA holder
BAYER AG
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Xarelto 10 mg film-coated tablets

PRD3003300 · Product

Active substance
Rivaroxaban
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
30 mg milligram(s)
Max total dose
2700 mg milligram(s)
Max treatment duration
90 Day(s)
Authorisation status
Authorised
ATC code
B01AF01 — -
Marketing authorisation
EU/1/08/472/009
MA holder
BAYER AG
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Xarelto 10 mg film-coated tablets

PRD3003289 · Product

Active substance
Rivaroxaban
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
30 mg milligram(s)
Max total dose
2700 mg milligram(s)
Max treatment duration
90 Day(s)
Authorisation status
Authorised
ATC code
B01AF01 — -
Marketing authorisation
EU/1/08/472/003
MA holder
BAYER AG
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Xarelto 10 mg film-coated tablets

PRD3003295 · Product

Active substance
Rivaroxaban
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
30 mg milligram(s)
Max total dose
2700 mg milligram(s)
Max treatment duration
90 Day(s)
Authorisation status
Authorised
ATC code
B01AF01 — -
Marketing authorisation
EU/1/08/472/006
MA holder
BAYER AG
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Lixiana 15 mg film-coated tablets

PRD2965632 · Product

Active substance
Edoxaban
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
60 mg milligram(s)
Max total dose
5400 mg milligram(s)
Max treatment duration
90 Day(s)
Authorisation status
Authorised
ATC code
B01AF03 — -
Marketing authorisation
EU/1/15/993/016
MA holder
DAIICHI SANKYO EUROPE GMBH
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Lixiana 15 mg film-coated tablets

PRD2965631 · Product

Active substance
Edoxaban
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
60 mg milligram(s)
Max total dose
5400 mg milligram(s)
Max treatment duration
90 Day(s)
Authorisation status
Authorised
ATC code
B01AF03 — -
Marketing authorisation
EU/1/15/993/001
MA holder
DAIICHI SANKYO EUROPE GMBH
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Comparator 15

Brilique 60 mg film-coated tablets

PRD3779152 · Product

Active substance
Ticagrelor
Substance synonyms
AZD6140
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
90 mg milligram(s)
Max total dose
8100 mg milligram(s)
Max treatment duration
90 Day(s)
Authorisation status
Authorised
ATC code
B01AC24 — -
Marketing authorisation
EU/1/10/655/008
MA holder
ASTRAZENECA AB
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Brilique 60 mg film-coated tablets

PRD3779151 · Product

Active substance
Ticagrelor
Substance synonyms
AZD6140
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
90 mg milligram(s)
Max total dose
8100 mg milligram(s)
Max treatment duration
90 Day(s)
Authorisation status
Authorised
ATC code
B01AC24 — -
Marketing authorisation
EU/1/10/655/007
MA holder
ASTRAZENECA AB
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Brilique 60 mg film-coated tablets

PRD3779154 · Product

Active substance
Ticagrelor
Substance synonyms
AZD6140
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
90 mg milligram(s)
Max total dose
8100 mg milligram(s)
Max treatment duration
90 Week(s)
Authorisation status
Authorised
ATC code
B01AC24 — -
Marketing authorisation
EU/1/10/655/011
MA holder
ASTRAZENECA AB
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Brilique 60 mg film-coated tablets

PRD3779153 · Product

Active substance
Ticagrelor
Substance synonyms
AZD6140
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
90 mg milligram(s)
Max total dose
8100 mg milligram(s)
Max treatment duration
90 Day(s)
Authorisation status
Authorised
ATC code
B01AC24 — -
Marketing authorisation
EU/1/10/655/009
MA holder
ASTRAZENECA AB
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Brilique 60 mg film-coated tablets

PRD3779072 · Product

Active substance
Ticagrelor
Substance synonyms
AZD6140
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
90 mg milligram(s)
Max total dose
8100 mg milligram(s)
Max treatment duration
90 Day(s)
Authorisation status
Authorised
ATC code
B01AC24 — -
Marketing authorisation
EU/1/10/655/010
MA holder
ASTRAZENECA AB
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Clopidogrel ratiopharm 75 mg film-coated tablets

PRD3190000 · Product

Active substance
Clopidogrel
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
75 mg milligram(s)
Max total dose
6750 mg milligram(s)
Max treatment duration
90 Day(s)
Authorisation status
Authorised
ATC code
B01AC04 — CLOPIDOGREL
Marketing authorisation
EU/1/14/975/009
MA holder
TEVA B.V
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Clopidogrel ratiopharm 75 mg film-coated tablets

PRD3189978 · Product

Active substance
Clopidogrel
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
75 mg milligram(s)
Max total dose
6750 mg milligram(s)
Max treatment duration
90 Day(s)
Authorisation status
Authorised
ATC code
B01AC04 — CLOPIDOGREL
Marketing authorisation
EU/1/14/975/004
MA holder
TEVA B.V
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Clopidogrel ratiopharm 75 mg film-coated tablets

PRD3189950 · Product

Active substance
Clopidogrel
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
75 mg milligram(s)
Max total dose
6750 mg milligram(s)
Max treatment duration
90 Day(s)
Authorisation status
Authorised
ATC code
B01AC04 — CLOPIDOGREL
Marketing authorisation
EU/1/14/975/003
MA holder
TEVA B.V
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Clopidogrel ratiopharm 75 mg film-coated tablets

PRD3189971 · Product

Active substance
Clopidogrel
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
75 mg milligram(s)
Max total dose
6750 mg milligram(s)
Max treatment duration
90 Day(s)
Authorisation status
Authorised
ATC code
B01AC04 — CLOPIDOGREL
Marketing authorisation
EU/1/14/975/005
MA holder
TEVA B.V
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Clopidogrel ratiopharm 75 mg film-coated tablets

PRD3189941 · Product

Active substance
Clopidogrel
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
75 mg milligram(s)
Max total dose
6750 mg milligram(s)
Max treatment duration
90 Day(s)
Authorisation status
Authorised
ATC code
B01AC04 — CLOPIDOGREL
Marketing authorisation
EU/1/14/975/002
MA holder
TEVA B.V
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Clopidogrel ratiopharm 75 mg film-coated tablets

PRD3189942 · Product

Active substance
Clopidogrel
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
75 mg milligram(s)
Max total dose
6750 mg milligram(s)
Max treatment duration
90 Day(s)
Authorisation status
Authorised
ATC code
B01AC04 — CLOPIDOGREL
Marketing authorisation
EU/1/14/975/007
MA holder
TEVA B.V
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Clopidogrel ratiopharm 75 mg film-coated tablets

PRD3189940 · Product

Active substance
Clopidogrel Hydrogen Sulfate
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
75 mg milligram(s)
Max total dose
6750 mg milligram(s)
Max treatment duration
90 Day(s)
Authorisation status
Authorised
ATC code
B01AC04 — CLOPIDOGREL
Marketing authorisation
EU/1/14/975/001
MA holder
TEVA B.V
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Clopidogrel ratiopharm 75 mg film-coated tablets

PRD3189943 · Product

Active substance
Clopidogrel
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
75 mg milligram(s)
Max total dose
6750 mg milligram(s)
Max treatment duration
90 Day(s)
Authorisation status
Authorised
ATC code
B01AC04 — CLOPIDOGREL
Marketing authorisation
EU/1/14/975/008
MA holder
TEVA B.V
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Clopidogrel ratiopharm 75 mg film-coated tablets

PRD3189958 · Product

Active substance
Clopidogrel
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
75 mg milligram(s)
Max total dose
6750 mg milligram(s)
Max treatment duration
90 Day(s)
Authorisation status
Authorised
ATC code
B01AC04 — CLOPIDOGREL
Marketing authorisation
EU/1/14/975/006
MA holder
TEVA B.V
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Aspirin 500 mg überzogene Tabletten

PRD1732336 · Product

Active substance
Acetylsalicylic Acid
Pharmaceutical form
COATED TABLET
Route of administration
ORAL USE
Max daily dose
325 mg milligram(s)
Max total dose
29250 mg milligram(s)
Max treatment duration
90 Day(s)
Authorisation status
Authorised
ATC code
N02BA01 — ACETYLSALICYLIC ACID
Marketing authorisation
86750.00.00
MA holder
BAYER VITAL GMBH
MA country
Germany
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Icahn School Of Medicine At Mount Sinai

Sponsor organisation
Icahn School Of Medicine At Mount Sinai
Address
1 Gustave L Levy Place
City
New York
Postcode
10029-6504
Country
United States

Scientific contact point

Organisation
Icahn School Of Medicine At Mount Sinai
Contact name
Anne Christine Gelijns

Public contact point

Organisation
Icahn School Of Medicine At Mount Sinai
Contact name
Jonathan Hupf

Locations

1 EU/EEA country · 16 investigational sites

By country

CountryMS statusPlanned subjectsSites
Germany Ongoing, recruiting 750 16
Rest of world
Brazil, United Kingdom, United States, Canada
 — 2,450 —

Investigational sites

Germany

16 sites · Ongoing, recruiting
Klinikum der Universitaet Muenchen AöR
Herzchirurgische Klinik und Poliklinik, Marchioninistrasse 15, Hadern, Munich
Universitaetsklinikum Duesseldorf AöR
Klinik für Herzchirurgie, Moorenstrasse 5, Bilk, Duesseldorf
Universitaetsklinikum Aachen AöR
Klinik für Herzchirurgie, Pauwelsstrasse 30, 52074, Aachen
Barmherzige Brueder Trier gGmbH
Herz- und Thoraxchirurgie, Nordallee 1, Trier-Nord, Trier
Goethe University Frankfurt
Klinik für Herz- und Gefäßchirurgie, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Herzzentrum Leipzig GmbH
Klinik für Herzchirurgie, Struempellstrasse 39, Probstheida, Leipzig
Friedrich-Schiller-Universitaet Jena
Klinik für Herz- und Thoraxchirurgie, Am Klinikum 1, Lobeda, Jena
Klinikum Oldenburg AöR
Universitätsklinik für Herzchirurgie, Rahel-Straus-Strasse 10, Kreyenbrueck, Oldenburg
Medical Center - University Of Freiburg
Universitäts-Herzzentrum Freiburg - Bad Krozingen, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau
Kerckhoff-Klinik GmbH
Herzzentrum / Abt. für Herzchirurgie und Chirurgische Intensivmedizin, Benekestrasse 2-8, 61231, Bad Nauheim
Otto Von Guericke Universitaet Magdeburg
Universitätsklinik für Herz- und Thoraxchirurgie, Leipziger Strasse 44, Leipziger Str., Magdeburg
Universitaetsklinikum Bonn AöR
Klinik und Poliklinik für Herzchirurgie, Venusberg-Campus 1, Venusberg, Bonn
Charite Universitaetsmedizin Berlin KöR
DHZB Deutsches Herzzentrum Berlin, Klinik für Herz-, Thorax- und Gefäßchirurgie, Augustenburger Platz 1, Wedding, Berlin
University Medical Center Hamburg-Eppendorf
Universitäres Herz- und Gefäßzentrum Hamburg, Martinistrasse 52, Eppendorf, Hamburg
Deutsches Herzzentrum Muenchen Klinikum Der Technischen Universitaet Muenchen
Klinik für Herz- und Gefäßchirurgie, Lazarettstrasse 36, Neuhausen-Nymphenburg, Munich
Martin-Luther-Universitaet Halle-Wittenberg
University Hospital Halle, Dep. of Cardiac Surgery, Ernst-Grube-Strasse 40, Kroellwitz, Halle (Saale)

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Germany 2023-01-16 2023-01-24

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 15 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_PACeS Protocol 1
Protocol (for publication) D1_PACeS_AMG_p 1
Recruitment arrangements (for publication) K1_Recruitment_arrangements 1
Subject information and informed consent form - Extract (for publication) PACeS_Kenntnisnahme_Nachinformation_PIC_2025-05-06 1
Subject information and informed consent form (for publication) L1_PACeS_Patinfo_EWE_AMG_p 2
Summary of Product Characteristics (SmPC) (for publication) Aspirin 2
Summary of Product Characteristics (SmPC) (for publication) Brilique 60 mg Filmtabletten 2
Summary of Product Characteristics (SmPC) (for publication) Clopidogrel ratiopharm 75 mg Filmtabletten 2
Summary of Product Characteristics (SmPC) (for publication) Eliquis_Apixaban_2023-05 1
Summary of Product Characteristics (SmPC) (for publication) Lixiana_Edoxaban_2023-11 1
Summary of Product Characteristics (SmPC) (for publication) Marcumar_Phenoprocoumon 2
Summary of Product Characteristics (SmPC) (for publication) Pradaxa_Dabigatran_2023-12 1
Summary of Product Characteristics (SmPC) (for publication) Rivaroxaban_Xarelto 2
Synopsis of the protocol (for publication) D1_PACeS_Synopse 2
Synopsis of the protocol (for publication) D1_PACeS_Synopsis 2

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-07-04 Germany Acceptable
2024-07-22
 2024-07-29
2 SUBSTANTIAL MODIFICATION SM-1 2025-05-06 Germany Acceptable
2025-06-10
 2025-06-11