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NCT03224923
A Novel Strategy For Personalized Long-Term Dual Antiplatelet Therapy (RAPID EXTEND PILOT STUDY)
Phase 4 trial testing Ticagrelor 60mg in Stable Coronary Syndrome in 5 participants. Terminated before completion.
30 September 2018
Quick facts
| Lead sponsor | Ottawa Heart Institute Research Corporation |
|---|---|
| Phase | Phase 4 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 5 |
| Start date | 18 August 2017 |
| Primary completion | 30 September 2018 |
| Estimated completion | 30 September 2018 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Ticagrelor 60mg — full drug profile →
- Clopidogrel 75mg — full drug profile →
- Aspirin 81 mg — full drug profile →
Conditions studied
- Stable Coronary Syndrome — all drugs for Stable Coronary Syndrome →
- Percutaneous Coronary Intervention — all drugs for Percutaneous Coronary Intervention →
- Antiplatelet Therapy — all drugs for Antiplatelet Therapy →
- Ticagrelor — all drugs for Ticagrelor →
Sponsor
Ottawa Heart Institute Research Corporation
Who can join
50 and older, any sex, with Stable Coronary Syndrome or Percutaneous Coronary Intervention. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In patients with heart attacks, the current standard of care is to restore blood flow through percutaneous coronary intervention (PCI). This is done using stents (metal meshes) that opens up blockages. Following PCI, standard preventative drug treatment includes the use of dual antiplatelet therapy (DAPT) using both aspirin and a platelet P2Y12 receptor inhibitor (Ticagrelor 90 mg twice a day or Clopidogrel 75 mg once a day) for one year to prevent clotting that can result in additional heart attacks, sudden clotting of stents or death. New studies have shown that there is a benefit to continuing DAPT beyond this one year mark. Longer-term DAPT has been shown to reduce ischemic events (heart attack, stroke) but increase the risk of bleeding. Present guidelines state that the decision to continue DAPT beyond the one year mark should be made on an individualized basis. The present study is a "pilot study" that seeks to compare Long-Term use of Ticagrelor (LTT) versus a Personalized Approach (PA). We will be recruiting patients who have been stable (free of ischemic or bleeding outcomes) on DAPT for 1 year after initial presentation with a heart attack. The PA group will use a modified DAPT score based on patient demographics to decide whether treatment is warranted. Patient will also undergo bedside genetic testing to identify potential at-risk genes. Those identified as carriers will be treated with ticagrelor while non-carriers will be treated with clopidogrel. The present study will determine whether a personalized approach will decrease bleeding versus an approach of universal ticagrelor use. The hypothesis is that patients receiving a personalized strategy will have a decreased risk of bleeding.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03224923
- Europe PMC full search
- ASCO Meeting Library
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- bioRxiv preprints
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Related trials
Other trials of Ticagrelor 60mg
Trials testing the same drug.
- NCT06228456 — Effects of Low-dose Ticagrelor vs. Clopidogrel in Stable Patients Undergoing Elective Percutaneous Coronary Intervention · Phase 4 · recruiting
- NCT05831462 — De-escalation of Ticagrelor in Post PPCI · Phase 1, PHASE2 · unknown
- NCT04718025 — Evaluation of Safety and Efficacy of Two Ticagrelor-based De-escalation Antiplatelet Strategies in Acute Coronary Syndro · Phase 3 · unknown
- NCT05283356 — Single Antiplatelet Treatment With Ticagrelor or Aspirin After Transcatheter Aortic Valve Implantation · Phase 4 · unknown
- NCT05210595 — Optimal Dosage of Ticagrelor in Korean Patients With AMI · Phase 4 · unknown
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 NCT03224923 (US National Library of Medicine, public domain)
- 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: 19 July 2019
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