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

March 8, 2011
May 16, 2012
April 2011
June 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01312935 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Reversal of Heparin in Patients Undergoing Percutaneous Coronary Intervention (PCI)
A Phase 2 Proof of Concept Study of PMX-60056 for the Reversal of Heparin in Patients Undergoing Percutaneous Coronary Intervention (PCI)

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

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Percutaneous Coronary Intervention
  • Coronary Artery Disease (CAD)
  • Angioplasty
Drug: PMX-60056
investigational drug
Experimental: Heparin and PMX-60056
Intervention: Drug: PMX-60056
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
17
August 2012
June 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01312935
PMX56-203
No
PolyMedix, Inc.
PolyMedix, Inc.
Not Provided
Not Provided
PolyMedix, Inc.
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP