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Safety of PZ-128 in Subjects Undergoing Non-Emergent Percutaneous Coronary Intervention

NCT02561000 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-04-16

Study results available
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Summary

The object of the study is to determine whether different doses of PZ-128, when added to standard medical care in persons undergoing cardiac catheterization/percutaneous coronary intervention, will increase the risk of bleeding.

A secondary objective is to determine whether patients treated with PZ-128 have fewer cardiac events such as heart attack, bypass surgery or stroke compared with those persons treated with the standard of care.

Conditions

  • Arterial Occlusive Diseases
  • Coronary Artery Disease
  • Coronary Disease
  • Arteriosclerosis
  • Heart Diseases
  • Myocardial Ischemia
  • Vascular Diseases
  • Acute Coronary Syndrome

Interventions

DRUG

PZ-128

DRUG

Placebo

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • RTI International

    collaborator OTHER

  • Inova Fairfax Hospital

    collaborator OTHER

  • University of Massachusetts, Worcester

    collaborator OTHER

  • Tufts Medical Center

    lead OTHER

Principal Investigators

  • Athan Kuliopulos, MD, PhD · Tufts Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-27
Primary Completion
2019-09-17
Completion
2019-09-17

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT02561000 on ClinicalTrials.gov