Conditions: Myocardial Infarction Heart Failure Heart Enlargement
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 253
Healthy volunteers: no

Brief summary:
The main purpose of the study is to test whether a possible new drug (called PG-116800) can prevent some of the damage to heart muscle in patients who have had a heart attack. The study will also supply information regarding possible uses of this compound in cardiovascular disease.

Detailed description:
Heart attacks cause damage to heart muscle that can weaken the heart and lead to changes in the shape and pumping ability of the heart. These changes can lead to heart failure. An enzyme called metalloproteinase (MMP) plays a role in this damage.

The main purpose of the study is to test whether a possible new drug (called PG-116800) that interferes with the MMP enzyme can prevent some of the damage to heart muscle in patients who have had a heart attack. The study will also supply information regarding possible uses of this compound in cardiovascular disease.

This is a Phase II "proof-of-concept" study; that is, it is a first attempt to treat sick people with the drug to see if it works.

The study is interventional since we will be using a drug to interfere with the heart tissue damage that follows a heart attack.

Arms:
arm 1: PG-116800 tablet (200 mg) taken twice daily for 90 days arm 2: Placebo tablet taken twice daily for 90 days

Interventions: intervention 1: PG-116800 (given as PG-530742) intervention 2: Placebo tablet
Intervention descriptions: intervention 1: 200 mg tablet of PG-116800 (given as PG-530742)twice a day for 90 days intervention 2: placebo tablet, twice a day for 90 days

Protocol document: