Clinical trial NCT00067236: Study of Oral PG-116800 Following a Heart Attack
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study of Oral PG-116800 Following a Heart Attack
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Myocardial Infarction
Heart Failure
Heart Enlargement
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2003-08-14
Enrollment: 253
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion:

* Be at least 18 years of age but not older than 80 years of age at screening;
* Be diagnosed with a heart attack based on electrocardiogram (ECG) and cardiac enzymes criteria;
* The qualifying heart attack has to be a first heart attack;
* The qualifying heart attack has to result in a left ventricular ejection fraction (a measure of the working efficiency of the heart) between 15% and 40%.

Exclusion:

* Documented previous history of heart attack;
* Any past history of heart failure;
* Hemodynamic instability (no instability of circulatory system);
* History of congenital heart disease and cardiomyopathy (weakened heart muscle) associated with connective tissue disorders;
* Recent history or current moderate-to-severe kidney or liver impairment;
* Significant blood dyscrasias (disorders of the blood cells);
* Females who are currently: pregnant; breast-feeding; or are of childbearing potential.

Primary outcomes:
measure: Change From Baseline in Left Ventricular End Diastolic Volume Index (LVEDVi in mL/m2) at Day 90 Post Myocardial Infarction (MI)
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences and Central Arkansas Veterans Health Care System
state: Arkansas
city: Merced
country: United States
facility: Mercy Community Medical Center
state: California
city: Denver
country: United States
facility: Porter Adventist Hospital
state: Colorado
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
city: Atlantis
country: United States
facility: JFK Medical Center
state: Florida
city: Clearwater
country: United States
facility: Morton Plant Hospital
state: Florida
city: Atlanta
country: United States
facility: Piedmont Hospital
state: Georgia
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Abbott-Northwestern Hospital
state: Minnesota
city: St. Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
city: Rochester
country: United States
facility: Strong Memorial Hospital
state: New York
city: Charlotte
country: United States
facility: Presbyterian Hospital
state: North Carolina
city: Greensboro
country: United States
facility: Moses Cone Hospital
state: North Carolina
city: Oklahoma City
country: United States
facility: Oklahoma Heart Hospital
state: Oklahoma
city: Greensburg
country: United States
facility: Westmoreland Regional Hospital
state: Pennsylvania
city: Hershey
country: United States
facility: Hershey Medical Center
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Chattanooga
country: United States
facility: Memorial Hospital
state: Tennessee
city: Houston
country: United States
facility: Memorial Hermann Hospital
state: Texas
city: Morgantown
country: United States
facility: West Virginia University Hospital
state: West Virginia
city: Calgary
country: Canada
facility: Foothills Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Grey Nuns Hospital
state: Alberta
city: Campbell River
country: Canada
facility: Alder Medical Centre
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Victoria
country: Canada
facility: Victoria Heart Institute
state: British Columbia
city: St. John's
country: Canada
facility: St. John's HSC
state: New Brunswick
city: Halifax
country: Canada
facility: Queen Elizabeth II HSC
state: Nova Scotia
city: Newmarket
country: Canada
facility: Southlake Regional HC
state: Ontario
city: Scarborough
country: Canada
facility: Scarborough Grace Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto East General
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Fleurimont
country: Canada
facility: CHUS, Hopital Fleurimont
state: Quebec
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Centre, Royal Victoria Hospital
state: Quebec
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
city: Montreal
country: Canada
facility: Hopital Sacre-Coeur
state: Quebec
city: Ste-Foy
country: Canada
facility: Hopital Laval
state: Quebec
city: Bialystok
country: Poland
facility: Klinika Kardiologii, Panstwowy Szpital Kliniczny
city: Bydgoszcz
country: Poland
facility: Katedra i Klinika Kardiologii i Chorob Wewnetznych, Akademia Medyczna w Bydgoszczy
city: Katowice
country: Poland
facility: 1 Katedra Kardiologii Slaskiej Akademii Medycznej
city: Krakow
country: Poland
facility: Klinika Chorob Serca i Naczyn, Krakowski Szpital Specjalistyczny
city: Krakow
country: Poland
facility: Oddzial Kardiologii, Wojewodzki Szpital Specjalistyczny
city: Lodz
country: Poland
facility: Klinika Kardiologii IMW, Uniwersytet Medyczny w Lodzi
city: Poznan
country: Poland
facility: I Klinika Kardilogii Akademii Medycznej w Poznaniu
city: Szczecin
country: Poland
facility: Oddzial Internistyczno-Kardiologiczny, Samodzieiny Publiczny Wojewodzki Szpital Zespolony
city: Warszawa
country: Poland
facility: I Klinika Choroby Wiencowej, Instytut Kardiologii w Warszawie
city: Warszawa
country: Poland
facility: Klinika Choroby Wiencowej, Instytut Kardiologi w Warszawie
city: Warszawa
country: Poland
facility: Klinika Kardilogii Inwazyjnej, Centrainy Szpital MSWiA
city: Warszawa
country: Poland
facility: Klinika Kardiologii, Szpital Grochowski
Study officials:
affiliation: Procter and Gamble
name: Jose Brum, MD
role: STUDY_DIRECTOR
References: