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

Percutaneous Coronary Intervention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01312935
• Other study ID #: PMX56-203
• Status: Terminated
• Phase: Phase 2
• First received: March 8, 2011
• Last updated: May 16, 2012
• Start date: April 2011
• Est. completion date: August 2012

Study information

• Verified date: May 2012
• Source: PolyMedix, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: August 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angioplasty
• Coronary Artery Disease
• Coronary Artery Disease (CAD)
• Coronary Disease
• Myocardial Ischemia
• Percutaneous Coronary Intervention

Intervention

Drug:
• PMX-60056
investigational drug

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
PolyMedix, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Immediately post completion of PCI procedure, until 2 hours after last dose.	Yes