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Clopidogrel Monotherapy in Patients With High Bleeding Risk

NCT05223335 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2024-02-21

Study results available
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Summary

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).

Conditions

  • Bleeding Complications

Interventions

DRUG

Clopidogrel

75 mg/day

DRUG

Prasugrel

60 mg bolus then 10 mg daily

DRUG

Tricagrelor

180 mg bolus then 90 mg twice daily

Sponsors & Collaborators

Principal Investigators

  • Mandeep Singh, MD · Mayo Clinic

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-29
Primary Completion
2023-03-16
Completion
2023-03-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05223335 on ClinicalTrials.gov