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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
Phase 3 trial testing Ticagrelor in Atrial Fibrillation in 40 participants. Status unknown.
1 November 2023
Quick facts
| Lead sponsor | Ottawa Heart Institute Research Corporation |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 40 |
| Start date | 1 November 2018 |
| Primary completion | 1 November 2023 |
| Estimated completion | 15 December 2023 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Ticagrelor (ticagrelor) — full drug profile →
- Rivaroxaban (rivaroxaban) — full drug profile →
Conditions studied
- Atrial Fibrillation — all drugs for Atrial Fibrillation →
- Acute Coronary Syndrome — all drugs for Acute Coronary Syndrome →
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):
-
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
Verify or expand the search:
- PubMed search for NCT03331484
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Atrial Fibrillation
Currently open trials in the same condition.
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Other Ottawa Heart Institute Research Corporation trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03331484 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ottawa Heart Institute Research Corporation
- Last refreshed: 17 January 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03331484.
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