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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01312935
Recruitment Status : Terminated (PolyMedix decided to stop enrollment in both clinical trials due to observations of reductions in blood pressure.)
First Posted : March 11, 2011
Last Update Posted : May 17, 2012
Sponsor:
Information provided by (Responsible Party):
PolyMedix, Inc.

Tracking Information
First Submitted Date  ICMJE March 8, 2011
First Posted Date  ICMJE March 11, 2011
Last Update Posted Date May 17, 2012
Study Start Date  ICMJE April 2011
Estimated Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2011)
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. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reversal of Heparin in Patients Undergoing Percutaneous Coronary Intervention (PCI)
Official Title  ICMJE A Phase 2 Proof of Concept Study of PMX-60056 for the Reversal of Heparin in Patients Undergoing Percutaneous Coronary Intervention (PCI)
Brief Summary The study investigates the safety and efficacy of PMX-60056 for the Reversal of Heparin in Patients Undergoing Percutaneous Coronary Intervention (PCI)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Percutaneous Coronary Intervention
  • Coronary Artery Disease (CAD)
  • Angioplasty
Intervention  ICMJE Drug: PMX-60056
investigational drug
Study Arms  ICMJE Experimental: Heparin and PMX-60056
Intervention: Drug: PMX-60056
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 16, 2012)
17
Original Estimated Enrollment  ICMJE
 (submitted: March 9, 2011)
40
Estimated Study Completion Date  ICMJE August 2012
Estimated Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01312935
Other Study ID Numbers  ICMJE PMX56-203
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party PolyMedix, Inc.
Study Sponsor  ICMJE PolyMedix, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account PolyMedix, Inc.
Verification Date May 2012

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