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

Inotek Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Acute Myocardial Infarction

Treatments

Drug: INO-1001

Study type

Interventional

Funder types

Industry

Identifiers

NCT00271765

IPC-15-2003

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.