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TERMINATEDPHASE2

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)

NCT01312935•PolyMedix, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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.
+1 more criteria

Locations (3)

South Bend, Indiana, United States

Detroit, Michigan, United States

Rapid City, South Dakota, United States

Key Dates

Start Date

April 1, 2011

Primary Completion Date

June 1, 2012

Completion Date

August 1, 2012

Last Updated

May 17, 2012

Enrollment

ACTUAL participants

Conditions

Percutaneous Coronary InterventionCoronary Artery Disease (CAD)Angioplasty

Interventions

PMX-60056

DRUG

ELEVATE High-Risk PCI Pivotal Study

NCT07001332

High-Risk Percutaneous Coronary Intervention (High-risk PCI)

View study

RECRUITINGPHASE4

Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention

NCT06909565

Percutaneous Coronary InterventionPeripheral Endovascular Intervention

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 17, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

ELEVATE High-Risk PCI Pivotal Study

Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention

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