REDUAL PCI Real Life Registry

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Zuyderland Medisch Centrum Stichting

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

completed 7 May 2025

Decision date (initial)

2024-11-25

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-518666-27-00

EudraCT number

2020-005058-46

ClinicalTrials.gov

NCT04688723

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

A real world registry based Randomised controlled trial to compare dual therapy with Dabigatran/Ticagrelor to Dabigatran/Clopidogrel in patients with an indication for NOAC undergoing PCI in the setting of ACS.

Conditions and MedDRA coding

Acute coronary syndrome

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. In order to be eligible to participate in this study, the investigator should have carefully considered participation of the patient after extensively consideration between high risk of bleeding and risk of thromboembolic events. Furthermore, a subject must meet all of the following criteria: • Age ≥ 18 years • PCI and successful stenting with a Drug Eluting Stent (DES) • Patients having an indication for a NOAC or will start with oral anticoagulation (NOAC). Patients with permanent, persistent or paroxysmal atrial fibrillation are eligible. • Written informed consent. In addition to the inclusion criteria above, all patients should meet one of the following conditions: • Admission to the hospital with ACS (unstable angina, NSTEMI, STEMI) • High risk PCI as defined by the presence of one of the following conditions: o Chronic Total Occlusion o Two-stent bifurcation laesion o Total stent length of >60mm in initial procedure o Venous graft stenting • Or the presence of medically treated type I or II diabetes mellitus

Exclusion criteria 1

1. A potential subject who meets any of the following criteria will be excluded from participation in this study: • Patients unable or unwilling to comply with the protocol or with life expectancy shorter than the duration of the study • Glomerular filtration rate < 30 ml/min • Prior or planned mechanical heart valve prosthesis. Patients with (planned) Transcatheter Aortic Valve Implantation or Aortic Valve Replacement with bioprosthetic valve, are eligible for participation in this study. • Cardiogenic shock • Contra-indication for Dabigatran, Ticagrelor or Clopidogrel o Liver dysfunction (ALAT, ASAT, Alkaline phosphatase > 3x upper limit of normal) or liver disease (like hepatitis A, B, C) o Lesion or condition with a significant risk of serious bleeding, such as:  current or recent gastrointestinal ulceration;  malignant neoplasms with more bleeding risk;  recent brain / spinal cord injury;  recent surgery on the brain, spinal cord or eyes;  recent or history of intracranial haemorrhage;  oesophageal varices;  arteriovenous malformations;  vascular aneurysms; o severe intraspinal or intracerebral vascular abnormalities. o comedication with cyclosporine, itraconazole, ketoconazole (systemic) and glecaprevir / pibrentasvir, dronedarone, rifampicine, carbamazepine, St. Jan’s wort or phenytoin o Comedication with tacrolimus is not recommended. • Allergy to for Dabigatran, Ticagrelor or Clopidogrel • Pregnancy • Significant thrombocytopenia (platelet count < 50x10 9/L) • Major bleeding according to BARC ≥3 within the past 6 months. • Weight < 50 kg

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint is the first bleeding event (major and clinically relevant non-major), as defined by the Bleeding Academic Research Council (BARC) score ≥2 after 12 months follow-up (12).

Secondary endpoints 1

1. The secondary endpoints are efficacy endpoints of thromboembolic events (myocardial infarction, stroke, systemic embolism) and death. Other secondary endpoints are a composite endpoint of thromboembolic events or death, as well as the individual thromboembolic events and stent thrombosis.

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Zuyderland Medisch Centrum Stichting

Sponsor organisation

Zuyderland Medisch Centrum Stichting

Address

Henri Dunantstraat 5

City

Heerlen

Postcode

6419 PC

Country

Netherlands

Scientific contact point

Organisation

Zuyderland Medisch Centrum Stichting

Contact name

Stichting Zuyderland Medisch Centrum

Public contact point

Organisation

Zuyderland Medisch Centrum Stichting

Contact name

Stichting Zuyderland Medisch Centrum - Cardiology

Locations

1 EU/EEA country · 5 investigational sites

By country

Investigational sites

Results and documents

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

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 6 files

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

Application history

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