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

NCT ID: NCT01312935

Last Updated: 2012-05-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2012-08-31

Brief Summary

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

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.

Conditions

Percutaneous Coronary Intervention; Coronary Artery Disease (CAD); Angioplasty

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Heparin and PMX-60056

Group Type: EXPERIMENTAL

PMX-60056

Intervention Type: DRUG

investigational drug

Interventions

PMX-60056

investigational drug

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PolyMedix, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

South Bend, Indiana, United States

Detroit, Michigan, United States

Rapid City, South Dakota, United States

Countries

United States

Other Identifiers

PMX56-203

Identifier Type: -

Identifier Source: org_study_id