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Monotherapy with a P2Y12 inhibitor followed by a direct-acting oral anticoagulant in patients with ATRial fIbrillation undergoing suprafleX Cruz coronary stent implantation (MATRIX-2)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-509717-36-00
Acronym
MATRIX-2
Enrollment
1700
Registered
2024-08-13
Start date
2024-12-16
Completion date
Unknown
Last updated
2025-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AF patients who have undergone successful PCI

Brief summary

Major adverse cardiac or cerebral events (MACCE), defined as the composite of death from any cause, myocardial infarction, stroke, or non-CNS systemic embolism between randomization and up to 12 months, Major or clinically relevant non-major bleeding (MCB) defined according to the International Society of Thrombosis and Hemostasis (ISTH) criteria between randomization and up to 12 months

Detailed description

The individual components of each primary endpoints, The composite of death from cardiovascular causes, myocardial infarction, or stroke, The composite of death from cardiovascular causes, myocardial infarction, stroke or non-CNS systemic embolism, Death from cardiovascular or non-cardiovascular causes, The composite of stroke and non-CNS systemic embolism, Any stroke (including ischemic, hemorragic, and unknown types), Ischemic stroke, Hemorrhagic stroke, Transient ischemic attack, The composite of definite or probable stent thrombosis, Definite stent thrombosis, Hospitalization, The composite of death or hospitalization, Any target lesion revascularization, Any target vessel revascularization, Any revascularization, All bleeding events, also adjudicated according to BARC, TIMI or GUSTO scales, Transfusion rates both in patients with and/or without clinically detected overt bleeding

Interventions

DRUGRIVAROXABAN
DRUGAPIXABAN
DRUGTICAGRELOR
DRUGACETYLSALICYLIC ACID
DRUGDABIGATRAN
DRUGPRASUGREL
DRUGCLOPIDOGREL
DRUGEDOXABAN

Sponsors

Insel Gruppe AG
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Major adverse cardiac or cerebral events (MACCE), defined as the composite of death from any cause, myocardial infarction, stroke, or non-CNS systemic embolism between randomization and up to 12 months, Major or clinically relevant non-major bleeding (MCB) defined according to the International Society of Thrombosis and Hemostasis (ISTH) criteria between randomization and up to 12 months

Secondary

MeasureTime frame
The individual components of each primary endpoints, The composite of death from cardiovascular causes, myocardial infarction, or stroke, The composite of death from cardiovascular causes, myocardial infarction, stroke or non-CNS systemic embolism, Death from cardiovascular or non-cardiovascular causes, The composite of stroke and non-CNS systemic embolism, Any stroke (including ischemic, hemorragic, and unknown types), Ischemic stroke, Hemorrhagic stroke, Transient ischemic attack, The composite of definite or probable stent thrombosis, Definite stent thrombosis, Hospitalization, The composite of death or hospitalization, Any target lesion revascularization, Any target vessel revascularization, Any revascularization, All bleeding events, also adjudicated according to BARC, TIMI or GUSTO scales, Transfusion rates both in patients with and/or without clinically detected overt bleeding

Countries

Belgium, France, Germany, Italy, Netherlands, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026