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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)
EU CTIS ID: 2023-509717-36-00
What this study is testing
The objectives of this study are to assess the safety, in terms of major or clinically relevant non-major bleeding, and the efficacy in terms of major adverse cardiac and cerebral events of a P2Y12 inhibitor monotherapy regimen for 1 month followed by DOAC monotherapy long-term versus current standard of care consisting of triple antithrombotic therapy for up to one month (aspirin, P2Y12 inhibitor and DOAC) followed by dual antithrombotic therapy (P2Y12 inhibitor and DOAC) for 6 to 12 months and DOAC monotherapy thereafter, in AF patients undergoing PCI indicated for treatment with a DOAC after sirolimus-eluting Supraflex Cruz stent implantation and followed for a period of 15 months.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Brazil
- Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Brazil; Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.