Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05955365 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Monotherapy With P2Y12 Inhibitors in Patients With Atrial fIbrillation Undergoing Supraflex Stent Implantation

Study acronym: MATRIX-2
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary completion date: Sep 30, 2026 to Dec 31, 2027
    • Study completion date: Dec 31, 2026 to Jun 30, 2028
    v5
  2. Minor Site details revised at 3 of 15 sitesv4
  3. Notable Phase: Phase 3 to Phase 4v3 Show 4 more changesShow less
    • Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 1, 2023 to Dec 18, 2023
    • Study sites: 14 to 15
    • Eligibility criteria expanded, about 2 words
  4. Minor Study sites: 15 to 14
    • Interventions: Aspirin (Drug), DOAC (Drug), P2Y12 inhibitors (clopidogrel, ticagrelor, prasugrel) (Drug) to Aspirin (Drug), DOAC (Drug), P2Y12 inhibitor (Drug)
    • Secondary endpoints revised (37)
    v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Patients with atrial fibrillation undergoing percutaneous coronary intervention with stent implantation require treatment with different antithrombotic drugs. Oral anticoagulants are prescribed to reduce the risk of stroke associated with atrial fibrillation. Antiplatelet substances are prescribed after stent implantation to reduce the risk of adverse cardiac events such as myocardial infarction or stent thrombosis. Treatment with antithrombotic medications can cause bleeding complications, particularly when these substances are combined. The currently recommended standard strategy consists of treatment with 3 antithrombotic medications for at least 1 week up to one month, followed by treatment with two of these medications for up to 6-12 months after stent implantation. Thereafter, patients usually receive long-term treatment with only one drug, an anticoagulant. In the monotherapy group of this study, the investigators will investigate a strategy where only one antithrombotic drug will be used at a time. During the first month after stent implantation, the investigators will prescribe an antiplatelet medication, followed by an oral anticoagulant as monotherapy. This strategy might be associated with fewer bleeding complications, while protecting adequately against thrombotic events. In this study the investigators would like to investigate whether treatment with a single antithrombotic drug ("monotherapy strategy") is associated with benefits compared to the currently recommended combination therapy of antithrombotic medications ("standard-of-care strategy").
Trial Details
NCT Number NCT05955365
Lead Sponsor Insel Gruppe AG, University Hospital Bern
Collaborators: Sahajanand Medical Technologies Limited
Conditions
(from sponsor)
Percutaneous Coronary Intervention (PCI), Atrial Fibrillation (AF), Oral Anticoagulation, P2Y12 Inhibitor
Related terms Atrial Fibrillation
Enrollment 3,010 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov