Skip to main content
OpenTrials
Completed

NCT Number: NCT05223335

Clopidogrel Monotherapy in Patients With High Bleeding Risk

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bleeding Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

clopidogrel

Drug

75 mg/day

Prasugrel

Drug

60 mg bolus then 10 mg daily

Tricagrelor

Drug

180 mg bolus then 90 mg twice daily

Primary outcomes

  1. Ischemic Risk Post-PCI in High Bleed Risk Patients With Genotype-guided Single Antiplatelet Therapy

    Time frame: Through study completion, approximately 90 days.

    The number of participants to experience ischemic events as defined as cardiac deaths, spontaneous myocardial infarctions (MIs) and stent thrombosis after percutaneous intervention (PCI).

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Clopidogrel Monotherapy in High Bleeding Risk Patients Undergoing Percutaneous Coronary Interventions: A Safety Assessment, Pilot Study to Reduce Post-Discharge Bleeding

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 3, 2022
Registry last updated
Feb 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.