A Study of INO-1001, an Intravenous PARP (Poly [ADP Ribose] Polymerase) Inhibitor in Acute Heart Attack Patients Undergoing Primary Percutaneous Coronary Intervention

November 27, 2006 updated by: Inotek Pharmaceuticals Corporation

A Phase II Randomized, Placebo-Controlled, Single-Blind, Multi-Center Dose-Escalation Study to Evaluate Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics of a Single Intravenous Administration of INO-1001 in Subjects With ST-Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

The primary purpose of this study is to assess the safety of INO-1001 in subjects who have experienced a heart attack and are to be treated with coronary angioplasty.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Currently, heart attacks may be treated with clot-dissolving medicines, coronary angioplasty, or a combination of both. Unblocking of blood flow to the heart following coronary angioplasty can cause side effects such as heart tissue and blood vessel damage, abnormal heart rhythms and death of heart muscle cells.

In animal studies, the PARP enzyme has been shown to be involved in damaging heart muscle after the sudden unblocking of coronary arteries. INO-1001 blocks the PARP enzyme, and so it may reduce heart damage in humans who have had their coronary arteries unblocked after a heart attack.

A total of 40 patients will be selected and randomly assigned to either INO-1001 or placebo (sugar water). One dose only of the drug will be given prior to coronary angioplasty. Patients will be followed until 30 days after surgery.

The following information will be gathered: vital signs, symptoms, physical examination, blood and urine tests, electrocardiograms, and other information from medical charts.

The information provided in this listing is disclosed solely to comply with regulatory requirements. The drug INO-1001 has not yet been approved for marketing and is only available to patients who participate in a clinical trial and are chosen for the treatment group.

Study Type

Interventional

Enrollment

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel, 31096
        • Rambam Medical Center
      • Kfar Saba, Israel, 95847
        • Meir Medical Center
      • Petach Tikva, Israel, 49100
        • Rabin Medical Center
      • Petach Tikva, Israel, 49100
        • Hasharon Medical Center
      • Rehovot, Israel
      • Zerifin, Israel
        • Assaf Harofe Medical Centre
  • United States
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Holy Cross Hospital
    • Indiana
      • Valparaiso, Indiana, United States, 46383
        • Porter Hospital
    • Minnesota
      • St. Paul, Minnesota, United States, 55102
        • St. Paul Heart Clinic
    • New Jersey
      • Newark, New Jersey, United States
    • Ohio
      • Toledo, Ohio, United States, 43606
        • Toledo Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Hospital of the University of Pennsylvania
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Black Hills Cardiovascular Research
    • Vermont
      • Burlington, Vermont, United States
    • Virginia
      • Norfolk, Virginia, United States
        • Sentara Norfolk General Hospital
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects with acute myocardial infarction (as defined in protocol) with onset within 24 hours prior to randomization.
  • Scheduled for primary percutaneous coronary intervention within 3 hours of presentation at a hospital participating in this study.
  • Males and non-pregnant, non-lactating females.

Exclusion Criteria:

  • Subjects will be required to undergo a full medical review in order to exclude serious medical, or psychological illness prior to inclusion.
  • History of a hypersensitivity reaction to more than three drugs or mannitol.
  • Participation in any investigational study within 30 days of randomization
  • Treatment with certain restricted medications within a specified time prior to participation in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The safety of INO-1001 will be measured by evaluation of symptoms, vital signs, physical examination, laboratory data, electrocardiograms, etc.

Secondary Outcome Measures

Outcome Measure
The effect of INO-1001 on heart muscle damage will be evaluated by blood tests. Other blood tests will measure how INO-1001 is absorbed and removed by the body after exposure to different doses.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inotek Pharmaceuticals Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Study Completion

June 1, 2006

Study Registration Dates

First Submitted

January 3, 2006

First Submitted That Met QC Criteria

January 3, 2006

First Posted (Estimate)

January 4, 2006

Study Record Updates

Last Update Posted (Estimate)

November 29, 2006

Last Update Submitted That Met QC Criteria

November 27, 2006

Last Verified

November 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPC-15-2003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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