Reversal of Heparin in Patients Undergoing Percutaneous Coronary Intervention (PCI)

May 16, 2012 updated by: PolyMedix, Inc.

A Phase 2 Proof of Concept Study of PMX-60056 for the Reversal of Heparin in Patients Undergoing Percutaneous Coronary Intervention (PCI)

The study investigates the safety and efficacy of PMX-60056 for the Reversal of Heparin in Patients Undergoing Percutaneous Coronary Intervention (PCI)

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

PMX-60056 is being developed as a rapid and effective reversal agent for use in those situations where anticoagulation by heparin, or LMWH must be quickly stopped. Potential uses include reversal of anticoagulation induced to prevent clotting during surgical procedures, and rescue from cases of inadvertent or unexpected overdose.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • South Bend, Indiana, United States
    • Michigan
      • Detroit, Michigan, United States
    • South Dakota
      • Rapid City, South Dakota, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. The patient will undergo PCI for diagnostic and/or therapeutic purposes with a procedure that uses anticoagulation before the instrumentation and reversal of anticoagulation immediately after the procedure.
  2. Male or female patients of any race, aged 18-80 years old.
  3. The patient will be anti-coagulated with unfractionated heparin.
  4. The patient is medically stable and physically and mentally able to participate in this study.
  5. The patient has given written informed consent to participate in this study after fully understanding the implications and constraints of the protocol.

Exclusion Criteria:

  1. The patient requires emergency surgery under conditions which prevent compliance with this protocol or which might cause unacceptable risk to the patient.
  2. The patient requires any concomitant surgical procedures (e.g., carotid artery, CABG) during the PCI.
  3. The patient has received any investigational drug within 30 days of study enrollment, or has had any prior exposure to PMX-60056.
  4. The patient has any condition or abnormality which may, in the opinion of the Investigator, compromise the safety of the patient.
  5. The patient is pregnant or breast feeding.
  6. The patient is of childbearing potential and not under adequate contraceptive protection.
  7. The patient has a history of clinically significant hematologic disease including heparin-induced thrombocytopenia, bleeding disorders, or platelet count <100,000.
  8. Severe impaired hepatic function (SGOT, SGPT >2 x ULN).
  9. History of AIDS, ± HIV.
  10. History of allergy to heparin (beef or pig), protamine, or salmon.
  11. History of chronic alcohol or drug abuse within the last one year.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Heparin and PMX-60056
Drug: PMX-60056
investigational drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary outcome measure of this study is the ability to reverse the anticoagulant effects of heparin (as measured by ACT) to the same extent as is known for protamine. intravenous infusion of PMX-60056.
Time Frame: Immediately post completion of PCI procedure, until 2 hours after last dose.
Immediately post completion of PCI procedure, until 2 hours after last dose.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PolyMedix, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Anticipated)

June 1, 2012

Study Completion (Anticipated)

August 1, 2012

Study Registration Dates

First Submitted

March 8, 2011

First Submitted That Met QC Criteria

March 9, 2011

First Posted (Estimate)

March 11, 2011

Study Record Updates

Last Update Posted (Estimate)

May 17, 2012

Last Update Submitted That Met QC Criteria

May 16, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PMX56-203

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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