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MATRIX-2
NCT05955365Phase 4
Key facts
- Status
- Recruiting
- Start
- Dec 2023
- Primary completion
- Dec 2027
- Countries
- 9
- Sponsor
- Insel Gruppe
- Modality
- Small Molecules
- Drugs
- rivaroxaban
- Conditions
- Atrial fibrillation (AFib)
01
Overview
Phase 4, randomised, open-label trial of rivaroxaban in Atrial fibrillation (AFib) (2 arms), sponsored by Insel Gruppe. Primary endpoints: Major Adverse Cardiac or Cerebral Events at 15 months and Major or Clinically Relevant Non-major Bleeding at 12 months. Started Dec 2023; status: recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
Monotherapy strategy
P2Y12 inhibitor for 1 month, followed by DOAC for 11 months.
Standard of care strategy
Aspirin + P2Y12 inhibitor + DOAC for 1 month, followed by P2Y12 inhibitor + DOAC for 6-12 months, then DOAC.
03
Who it enrols
Adults with atrial fibrillation or flutter requiring DOAC for >=12 months, who had successful PCI within 7 days, excluding those with recent stroke, severe renal/hepatic impairment, or planned surgery.
04
Endpoints
Primary
Major Adverse Cardiac or Cerebral Events
Major or Clinically Relevant Non-major Bleeding
Secondary
Incidence of MACCE or MCB
Composite of death from cardiovascular causes, myocardial infarction or stroke
Composite of death from cardiovascular causes, myocardial infarction, stroke or non-CNS systemic embolism
Death from cardiovascular or non-cardiovascular causes
Composite of stroke and non-CNS systemic embolism
Any stroke (including ischemic, hemorrhagic and unknown types)
Ischaemic stroke
Hemorrhagic stroke
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