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NCT07025148 · ClinicalTrials.gov registry record · Phase 4
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)
A Phase 4 study of Coronary Arterial Disease (CAD) and Percutaneous Coronary Intervention (PCI), sponsored by University of Florida.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT07025148: Recruiting Phase 4 study of Coronary Arterial Disease (CAD) and Percutaneous Coronary Intervention (PCI), sponsored by University of Florida.
NCT07025148 is a Phase 4 study of Coronary Arterial Disease (CAD) and Percutaneous Coronary Intervention (PCI) that is actively recruiting participants, run by University of Florida. The registered enrollment target is 40 participants, below the 3,071-participant average among 5 other Coronary Arterial Disease (CAD) trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07025148, a Phase 4 study of Coronary Arterial Disease (CAD) and Percutaneous Coronary Intervention (PCI), is actively recruiting participants, sponsored by University of Florida.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The primary end point of our study will be levels of platelet reactivity, measured as P2Y12 reaction units (PRU) using the VerifyNow system in patients at dual-risk (both HBR and HIR \[ABCD-GENE score ≥10 points\]) between low-dose prasugrel (5 mg qd) vs. standard-dose clopidogrel (75 mg qd)
Conditions Studied
Interventions
- DRUG Clopidogrel
- DRUG Prasugrel
Study Locations (1)
Florida
- University of Florida Health - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2025-10-01 |
| Est. Completion | 2027-11-01 |
| Phase | Phase 4 |
What NCT07025148 shows while recruiting
NCT07025148 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 3,071-participant average among 5 other Coronary Arterial Disease (CAD) trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Coronary Arterial Disease (CAD) appearing as the primary indexed condition, and to 2 interventions - of which Clopidogrel is the first listed.
NCT07025148 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT07025148 about?
NCT07025148 is a clinical study titled "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)". 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 hy...
What is the current status of trial NCT07025148?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2025-10-01. Estimated completion is 2027-11-01.
What conditions does trial NCT07025148 study?
This clinical trial studies the following conditions: Coronary Arterial Disease (CAD), Percutaneous Coronary Intervention (PCI).
What interventions are being tested in trial NCT07025148?
The interventions under investigation include: Clopidogrel (DRUG), Prasugrel (DRUG).
Who is sponsoring clinical trial NCT07025148?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07025148 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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