Clopidogrel Monotherapy in Patients With High Bleeding Risk

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-29

Study Completion Date

2023-03-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this research is to show that a shorter duration of two antiplatelet medications (compared to the standard of care) is safe and effective while reducing the risk of bleeding complications. Bleeding complications can cause significant problems (hospitalizations, need for blood transfusions, and even death) for patients on antiplatelet medications after coronary stents. Researchers hope to show that reducing the time on two antiplatelet agents in patients at high risk for these bleeding complications will reduce the number of bleeding events while not causing any increase in cardiovascular complications (heart attack, stent malfunction, death).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Sampling P2Y12 Receptor Inhibition With Prasugrel and Ticagrelor in Patients Submitted to Thrombolysis

NCT02215993

Acute Coronary Syndrome Platelet Function

COMPLETED PHASE4

Clinical Management of Antiplatelet Drug Resistance in Patients With Drug Eluting Coronary Stents

NCT00589862

Coronary Artery Disease

WITHDRAWN PHASE4

Evaluating Additional Platelet Inhibition in Patients With High Platelet Reactivity Undergoing Percutaneous Coronary Intervention

NCT01339026

Cardiovascular Disease Acute Coronary Syndrome

TERMINATED PHASE4

Endothelium, Stenting, and Antiplatelet Therapy (EST) - Clopidogrel, Prasugrel, Ticagrelor Study

NCT01700322

Coronary Artery Disease

COMPLETED PHASE4

Trial in Subjects Undergoing Cardiac Catheterization With Planned Percutaneous Coronary Intervention With Stenting

NCT00357968

Coronary Artery Disease

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bleeding Complications

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Genotype-Guided Therapy

Subjects with high bleeding risk (HBR) on dual antiplatelet therapy (DAPT) with clopidogrel and aspirin, that have undergone successful percutaneous coronary intervention (PCI) will be stratified by the CYP2C19 loss-of-function (LOF) allele within one week of DAPT initiation. In this group, subjects identified as CYP2C19\*2 or\*3 LOF allele carrier will be given prasugrel or ticagrelor monotherapy.

Group Type EXPERIMENTAL

Prasugrel

Intervention Type DRUG

60 mg bolus then 10 mg daily

Tricagrelor

Intervention Type DRUG

180 mg bolus then 90 mg twice daily

Conventional Therapy

Subjects with high bleeding risk (HBR) on dual antiplatelet therapy (DAPT) with clopidogrel and aspirin, that have undergone successful percutaneous coronary intervention (PCI) will be stratified by the CYP2C19 loss-of-function (LOF) allele within one week of DAPT initiation. In this group, subjects identified as CYp2C19\*2 or\*3 LOF allele non-carriers will continue with clopidogrel monotherapy.

Group Type ACTIVE_COMPARATOR

Clopidogrel

Intervention Type DRUG

75 mg/day

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Clopidogrel

75 mg/day

Intervention Type DRUG

Prasugrel

60 mg bolus then 10 mg daily

Intervention Type DRUG

Tricagrelor

180 mg bolus then 90 mg twice daily

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Informed consent in adults
* Successful percutaneous coronary intervention (PCI) \[no non-fatal myocardial infarction (MI)/stroke/repeat target revascularization/bleeding/acute kidney injury\].
* Academic research consortium-high bleeding risk (ARC-HBR) score ≥ 4.

Exclusion Criteria

* Chronic use of warfarin or direct oral anticoagulant (DOAC).
* Unsuccessful PCI (see above).
* Lesions with angiographic thrombus.
* Prior PCI within 6 months.
* Planned PCI or surgical intervention to treat any cardiac or noncardiac condition within 6 months.
* High risk lesion/stent characteristics (\> 50% unprotected left main disease, bifurcation disease requiring 2 stents technique, rotational atherectomy.
* Vein graft.
* Unprotected left main intervention or history of definite stent thrombosis.
* Women of child-bearing age unless negative pregnancy test is done.
* Life expectancy \< 1 year.
* Known drug/alcohol dependence.
* Assessment that the patient will not be compliant with the study protocol.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No