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

History of Changes

Tracking Information
First Received Date ^ICMJE	March 8, 2011
Last Updated Date	May 16, 2012
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. ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01312935 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	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	Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Percutaneous Coronary Intervention Coronary Artery Disease (CAD) Angioplasty
Intervention ^ICMJE	Drug: PMX-60056 investigational drug
Study Arm (s)	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
Enrollment ^ICMJE	17
Estimated Completion Date	August 2012
Estimated Primary Completion Date	June 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: 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. Exclusion Criteria: 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.
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01312935
Other Study ID Numbers ^ICMJE	PMX56-203
Has Data Monitoring Committee	No
Responsible Party	PolyMedix, Inc.
Study Sponsor ^ICMJE	PolyMedix, Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	PolyMedix, Inc.
Verification Date	May 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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