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NCT03331484: CAPITAL PCI AF

The Safety and Efficacy Of Rivaroxaban and Ticagrelor for Patients With Atrial Fibrillation After Percutaneous Coronary Intervention

Status unknown Phase 3 Last updated 17 January 2023
What this trial tests

Phase 3 trial testing Ticagrelor in Atrial Fibrillation in 40 participants. Status unknown.

Timeline
1 November 2018
Primary endpoint
1 November 2023
15 December 2023

Quick facts

Lead sponsorOttawa Heart Institute Research Corporation
PhasePhase 3
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeprevention
Enrollment40
Start date1 November 2018
Primary completion1 November 2023
Estimated completion15 December 2023
Sites1 location across Canada

Drugs / interventions tested

Conditions studied

Sponsor

Ottawa Heart Institute Research Corporation

Who can join

18 and older, any sex, with Atrial Fibrillation or Acute Coronary Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Currently, there is minimal data on the combination of rivaroxaban and ticagrelor in patients with atrial fibrillation (AF) managed with percutaneous coronary intervention (PCI). Furthermore, there exists significant controversy among physicians in the use of oral anticoagulants in conjunction with antiplatelet therapy in this population. The present recommendation is triple therapy (aspirin + clopidogrel + warfarin), which has been related to major bleeding complications. Previous studies have shown that ticagrelor has been proven to be more effective in reducing the rate of death, new heart attacks, or strokes than the previously recommended drug, clopidogrel, and studies have shown that less bleeding occurs with rivaroxaban than with warfarin. Therefore, it would be ideal to investigate the two potent drugs, ticagrelor and rivaroxaban, in combination in order to gain insight in the management of these high-risk patients. The CAPITAL PCI AF study is a phase 3 Health Canada regulated interventional study involving the use of investigational drugs. It is a non-randomized, open-design study. The investigational team is studying the highly potent drug Ticagrelor, which is prescribed to participants receiving a stent placement, given in combination with Rivaroxaban, an oral anticoagulant recommended for patients with AF. The primary clinical endpoint is a safety outcome measuring bleeding complications in participants with AF treated within one year of the index PCI. The primary efficacy endpoint is measured by the clinical outcomes of death, stroke, non-central nervous system systemic embolism, myocardial infarction, and stent thrombosis within one year of the index PCI.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Platelet biology and function: plaque erosion vs. rupture.
    Baaten CCFMJ, Nagy M, Bergmeier W, Spronk HMH, et al · · 2024 · cited 70× · PMID 37940193 · DOI 10.1093/eurheartj/ehad720

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Other trials of Ticagrelor

Trials testing the same drug.

Other recruiting trials for Atrial Fibrillation

Currently open trials in the same condition.

Other Ottawa Heart Institute Research Corporation trials

Trials by the same sponsor.

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Data sources for this page

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