Evaluation of safety i efficacy de-escalation antiplatelet strategies in acute coronary syndrome.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Nicolaus Copernicus University

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

7 Feb 2022 → 3 Apr 2026

Decision date (initial)

2024-11-24

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Medical Research Agency

External identifiers

EU CT number

2024-518090-34-00

EudraCT number

2020-005130-15

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy, Safety

The primary objective of this study is to assess and compare clinical safety of two ticagrelor-based antiplatelet de-escalation strategies with standard dual antiplatelet therapy (DAPT).

Secondary objectives 1

1. The secondary objective of the study is compare clinical efficacy of two ticagrelor-based antiplatelet de-escalation strategies with standard DAPT.

Conditions and MedDRA coding

Acute Coronary Syndrom (ACS)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Subject has signed Informed Consent Form and is able to understand the purpose and procedures required for the study and is willing to participate in the study.
2. Subject is aged 18 and older.
3. Subject is able to understand and comply with the protocol requirements and instructions and is likely to complete the and is diagnosed with ACS, including ST-elevation myocardial infarction (STEMI), non ST elevation myocardial infarction (NSTEMI) or unstable angina (UA). The diagnosis of STEMI and NSTEMI will be made according to the Fourth Universal Definition of Myocardial Infarction, and UA will be diagnosed according to the 2020 European Society of Cardiology (ESC) Guidelines for the management of ACS in patients presenting without persistent ST-segment elevation (NSTE ACS). For patients with STEMI the following three inclusion criteria will have to be met: 1) new ST-elevation at the J-point in two contiguous leads with the cut-point ≥1 mm in all leads other than leads V2–V3, where the following cut-points apply: ≥2mm in men ≥40 years; ≥2.5 mm in men <40 years, or ≥1.5 mm in women regardless of age; or a new left bundle-branch block, and 2) the intention to perform primary percutaneous coronary intervention (PCI), and 3) detection of a rise and/or fall of cardiac troponin values with at least one value above the 99th percentile upper reference limit. For patients NSTEMI-ACS, at least two of the following three criteria will have to be met: 1) symptoms indicating myocardial ischemia; 2) ST-segment changes on electrocardiography indicating myocardial ischemia; 3) detection of a rise and/or fall of cardiac troponin values with at least one value above the 99th percentile upper reference limit; in addition to at least one of the following: - ≥60 years of age; - previous myocardial infarction or coronary artery by-pass grafting; - ≥50% stenosis in ≥2 coronary arteries; - previous ischemic stroke or Transient Ischemic Attack (TIA); - ≥50% carotid stenosis or cerebral revascularization; - diabetes mellitus; - peripheral artery disease; - chronic kidney disease with glomerular filtration rate <60 mL/min. study as planned

Exclusion criteria 9

1. Contraindication to ticagrelor or/and ASA.
2. Need for use of any oral anticoagulation therapy.
3. Second or third grade atrio-ventricular block.
4. Previous stent thrombosis on treatment with ticagrelor.
5. End stage kidney disease with glomerular filtration rate <15 mL/min or on haemodialysis;
6. Administration of prasugrel during the index event;
7. Unreliability or lack of cooperation.
8. Pregnancy.
9. As per the Investigator (or his designee) judgment, subject cannot participate in the study for any reason (e.g., medical, psychiatric and/or social reason).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 4

1. The primary end point os this project is the first occurrence of type 2, 3 or 5 bleeding according to the Bleeding Academic Research Consortium (BARC) criteria, within 12 months of observation, in a time-to-event analysis. BARC type 2 bleeding is any clinically overt sign of haemorrhage that is actionable and requires diagnostic studies, hospitalization, or treatment by a health care professional.
2. BARC type 3 bleeding is: a) overt bleeding with haemoglobin drop of 3 to <5 g/dL (provided it is related to bleed); transfusion with overt bleeding;
3. b) overt bleeding with hemoglobin drop ≥5 g/dL (provided it is related to bleed); cardiac tamponade; bleeding requiring surgical intervention for control; bleeding requiring intravenous vasoactive agents;c) intracranial haemorrhage confirmed by autopsy, imaging, or lumbar puncture; intraocular bleed compromising vision.
4. BARC type 5 bleeding is fatal bleeding.

Secondary endpoints 11

1. BARC type 3 or 5 bleeding
2. Thrombolysis in Myocardial Infarction (TIMI) major or minor bleeding
3. Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) moderate, severe, or life-threatening bleeding;
4. International Society of Thrombosis and Haemostasis (ISTH) major bleeding
5. death from any cause
6. death from Cardiovascular causes (CV);
7. myocardial infarction
8. ischemic stroke
9. definite or probable stent thrombosis
10. adherence to study treatment
11. dyspnea

Investigational products

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

Test 3

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Nicolaus Copernicus University

Sponsor organisation

Nicolaus Copernicus University

Address

Ul. Jurija Gagarina 11

City

Torun

Postcode

87-100

Country

Poland

Scientific contact point

Organisation

Nicolaus Copernicus University

Contact name

University Centre for Clinical Research Support at NCU Collegium Medicum

Public contact point

Organisation

Nicolaus Copernicus University

Contact name

University Centre for Clinical Research Support at NCU Collegium Medicum

Third parties 1

Locations

1 EU/EEA country · 30 investigational sites

By country

Investigational sites

Country notifications

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

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Unexpected events 1 · Art. 53 CTR

Note: SUSARs are reported via EudraVigilance, not CTIS — events shown here are CTIS-public notifications only.

Results and documents

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

Documents 7 files

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

Application history

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