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Direct Thrombin Inhibitor

Bivalirudin for Coronary Artery Disease (STATUS PCI Trial)

Phase 4
Waitlist Available
Led By Allen Jeremias, MD
Research Sponsored by Stony Brook University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Summary

The objective of the study is to assess the safety and efficacy of Angiomax® (bivalirudin) versus unfractionated heparin (UFH) in patients presenting with stable angina or silent ischemia (positive stress test without chest pain) that undergo percutaneous coronary intervention (PCI). The primary endpoint of the study will be major and minor bleeding events, defined by the REPLACE-2 trial definition, during the index hospitalization and up to 30 days post discharge.

Eligible Conditions
  • Coronary Artery Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Bleeding events
Secondary study objectives
MACE

Trial Design

2Treatment groups
Active Control
Group I: BivalirudinActive Control2 Interventions
Anticoagulation during percutaneous coronary intervention
Group II: Unfractionated HeparinActive Control1 Intervention
Anticoagulation during percutaneous coronary intervention

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Who is running the clinical trial?

Stony Brook UniversityLead Sponsor
222 Previous Clinical Trials
41,771 Total Patients Enrolled
2 Trials studying Coronary Artery Disease
125 Patients Enrolled for Coronary Artery Disease
Allen Jeremias, MDPrincipal InvestigatorStony Brook University
1 Previous Clinical Trials
312 Total Patients Enrolled
1 Trials studying Coronary Artery Disease
312 Patients Enrolled for Coronary Artery Disease
~16 spots leftby Oct 2025
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