Trials / Recruiting
RecruitingNCT07025148
Dual Antiplatelet Therapy Escalation From Standard-dose Clopidogrel to Low-Dose Prasugrel in Patients With High Bleeding and Ischemic Risk Undergoing PCI: A Prospective, Randomized Pharmacodynamic Study (TAILOR-BLEED-2)
Switching From Clopidogrel to Low-dose Prasugrel in Patients at Dual-risk Following Percutaneous Coronary Intervention (TAILOR-BLEED-2)
- Status
- Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- University of Florida · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary aim of this study is to investigate the PD effects of switching from standard-dose clopidogrel dose to low-dose prasugrel versus continuing standard-dose clopidogrel in patients at dual-risk (HBR defined as the HBR-ARC criteria and HIR defined as ABCD-GENE score ≥10) following PCI. We hypothesize that in patients at dual-risk, switching from standard-dose clopidogrel to low-dose prasugrel will be superior to continuing standard-dose clopidogrel in terms of platelet reactivity.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Prasugrel | Prasugrel 5 mg od for 30 ± 5 days |
| DRUG | Clopidogrel | Clopidogrel 75 mg od for 30 ± 5 days |
Timeline
- Start date
- 2025-10-01
- Primary completion
- 2027-08-01
- Completion
- 2027-11-01
- First posted
- 2025-06-17
- Last updated
- 2025-11-04
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07025148. Inclusion in this directory is not an endorsement.