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

This study has been terminated.
(PolyMedix decided to stop enrollment in both clinical trials due to observations of reductions in blood pressure.)
Sponsor:
Information provided by (Responsible Party):
PolyMedix, Inc.
ClinicalTrials.gov Identifier:
NCT01312935
First received: March 8, 2011
Last updated: May 16, 2012
Last verified: May 2012
  Purpose

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


Condition Intervention Phase
Percutaneous Coronary Intervention
Coronary Artery Disease (CAD)
Angioplasty
Drug: PMX-60056
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Proof of Concept Study of PMX-60056 for the Reversal of Heparin in Patients Undergoing Percutaneous Coronary Intervention (PCI)

Resource links provided by NLM:


Further study details as provided by PolyMedix, Inc.:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Enrollment: 17
Study Start Date: April 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Heparin and PMX-60056 Drug: PMX-60056
investigational drug

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01312935

Locations
United States, Indiana
South Bend, Indiana, United States
United States, Michigan
Detroit, Michigan, United States
United States, South Dakota
Rapid City, South Dakota, United States
Sponsors and Collaborators
PolyMedix, Inc.
  More Information

No publications provided

Responsible Party: PolyMedix, Inc.
ClinicalTrials.gov Identifier: NCT01312935     History of Changes
Other Study ID Numbers: PMX56-203
Study First Received: March 8, 2011
Last Updated: May 16, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by PolyMedix, Inc.:
Percutaneous Coronary Intervention
Heparin
Angioplasty
LMWH

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Calcium heparin
Heparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 23, 2014