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

NCT01312935 | Terminated Phase 2

• 1 other identifier: PMX56-203
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

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

Keywords

Percutaneous Coronary Intervention; Heparin; Angioplasty; LMWH

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Heparin and PMX-60056

EXPERIMENTAL

Drug: PMX-60056

Interventions

PMX-60056 DRUG

investigational drug

Heparin and PMX-60056

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• PolyMedix, Inc.: lead

Study Sites (3)

Unknown Facility

South Bend, Indiana, United States

Location

Unknown Facility

Detroit, Michigan, United States

Location

Unknown Facility

Rapid City, South Dakota, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2011
• First Posted: March 11, 2011
• Study Start: April 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: August 1, 2012
• Last Updated: May 17, 2012

Record last verified: 2012-05

Locations

US (3)