Treatment with a single drug that prevents blood clot formation followed by an anticoagulant drug in patients with irregular heartbeat who have undergone coronary blood flow restoration surgery with a stent (MATRIX-2)

Phase 1

• Conditions: AF patients who have undergone successful PCI; MedDRA version: 20.0Level: PTClassification code: 10051592Term: Acute coronary syndrome Class: 100000004849; MedDRA version: 20.0Level: PTClassification code: 10003658Term: Atrial fibrillation Class: 100000004849; MedDRA version: 24.0Level: PTClassification code: 10085242Term: Chronic coronary syndrome Class: 100000004849; MedDRA version: 20.0Level: PTClassification code: 10003662Term: Atrial flutter Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: CTIS2023-509717-36-00
• Lead Sponsor: Insel Gruppe AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-14
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1690

Inclusion Criteria

Age = 18 years, Atrial fibrillation or flutter with an indication for oral anticoagulation using direct-acting oral anticoagulants (DOACs) for = 12 months, Successful percutaneous coronary intervention in at least 1 lesion within the previous 7 days with no remaining lesions intended for treatment, Free from major adverse events post qualifying PCI, including new onset chest pain suspected to be of ischemic origin, acute or subacute stent thrombosis, new-onset neurological signs or symptoms, Written informed consent

Exclusion Criteria

Planned staged percutaneous intervention procedure, Moderate and severe hepatic imparment (Child-Pugh Class B or C) or any hepatic disease associated with coagulopathy, Any hypersensitivity or contraindications for direct oral anticoagulant or dual antiplatelet therapy with aspirin and a P2Y12 inhibitor, Any of the following abnormal local laboratory results prior to randomization: platelet count < 50x10^9/L or hemoglobin <8 g/dL, Known pregnancy or breast-feeding patients, Life expectancy <1 year due to other severe non-cardiac disease, Planned surgery including coronary artery bypass grafting within the next 6 months, Cardioversion for treatment of atrial fibrillation within 1 month prior to inclusion or planned cardioversion, Atrial fibrillation ablation procedure within 2 month prior to inclusion or planed atrial fibrillation ablation procedure, Prior mechanical valvular prosthesis implantation, Deep vein thrombosis/pulmonary embolism, at least moderately severe mitral stenosis or other clinical conditions than atrial fibrillation requiring long-term oral anticoagulation, Stroke within 1 month prior to randomization, Hemodynamic instability (persistent systolic blood pressure below 90 mmHg, continuous infusions of catecholamines, clinical signs of hypoperfusion and/or use of percutaneous left ventricular assist devices), Uncontrolled severe hypertension with a systolic blood pressure (BP) = 180 mmHg and/or diastolic BP = 120 mmHg, Severe renal impairment with estimated creatinine clearance (CrCL) < 15 mL/min or on dialysis

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified