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

Stopped early · Phase 2

Conditions studied: Percutaneous Coronary Intervention, Coronary Artery Disease (CAD), Angioplasty

In brief

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

Key facts

Study ID

NCT01312935

Run by

PolyMedix, Inc.

People needed

17

Starts

2011-04-01

Expected to finish

2012-08-01

Last updated by the study team

2012-05-17

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Male or female patients of any race, aged 18-80 years old.
• The patient will be anti-coagulated with unfractionated heparin.
• The patient is medically stable and physically and mentally able to participate in this study.
• The patient has given written informed consent to participate in this study after fully understanding the implications and constraints of the protocol.

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

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