Dual Therapy With Dabigatran/Ticagrelor Versus Dual Therapy With Dabigatran/Clopidogrel in ACS Patients With Indication for NOAC Undergoing PCI

• Status: Recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

Summary

A real world registry to compare dual therapy with Dabigatran/Ticagrelor to dual therapie with Dabigatran/Clopidogrel in patients with an indication for NOAC undergoing PCI in the setting of ACS. Hypothesis: Dual therapy with Dabigatran/Ticagrelor will be non-inferior in reducing the risk of bleeding compared to Dual therapy with Dabigatran/Clopidogrel (RE-DUAL PCI trial based) in patients with an indication for NOAC undergoing PCI in the setting of ACS. Thromboembolic events, stent thrombosis and death will be evaluated for estimation of events between both groups. Data will be pooled for this secondary endpoint with data from the upcoming WOEST-3 trial to compare both treatments.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zuyderland Medisch Centrum
• Collaborator: Boehringer Ingelheim
• Treatments: Clopidogrel; Dabigatran; Ticagrelor

Criteria

Inclusion Criteria:

• Age ≥ 18 years

• Patients having an indication for a NOAC or will start with oral anticoagulation (NOAC). Permanent, persistent or paroxysmal atrial fibrillation are eligible.

• PCI and successful stenting with DES for ACS (unstable angina pectoris, NSTEMI, STEMI)

• Written informed consent.

Exclusion Criteria:

• 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

• Heart valve prosthesis (mechanical or biological)

• Cardiogenic shock

• Contra-indication for Dabigatran, Ticagrelor or Clopidogrel

• Liver dysfunction (ALAT, ASAT, Alkaline phosphatase > 3x upper limit of normal) or liver disease (like hepatitis A, B, C)

• 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.

• 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