Hypertension - Clinical Trials
What is
PEACE?
PEACE is a multicenter clinical trial sponsored
by the National Heart, Lung and Blood Institute (NHLBI) of the National
Institutes of Health (NIH). The study is designed to determine if the ACE
inhibitor, trandolapril, a drug approved by the FDA and used to treat high blood
pressure and heart failure, can also reduce the risk of heart attacks, death or
revascularization procedures such as balloon angioplasty or coronary artery
bypass surgery in patients with coronary artery disease.
8100 patients will join the PEACE trial and will
be followed for an average of 5.5 years at more than 150 clinical sites in the
United States, Canada, Italy and Puerto Rico. The first patient was enrolled in
November 1996 . It is planned to continue recruitment through December 1999 and
follow-up through December 2003.
I. Inclusion
Criteria
- Men and women > 50 years of age at
the time of randomization.
- Coronary artery disease documented as at least
one of the following:
- a. A documented myocardial infarction at least
three months prior to randomization.
- b. A CABG or PTCA at least three months prior
to randomization.
- c. A coronary angiogram demonstrating the presence of at least one native
coronary obstruction (non-bypassed) of > 50% luminal diameter. The
qualifying lesion(s) will be based on the most recent study.
- Left ventricular function:
- a. Ejection fraction > 40% as determined by contrast ventriculography,
radionuclide ventriculography, or echocardiography performed less than 18 months
prior to the date of randomization.
OR
-
- b. A qualitatively normal echo or angiogram of the LV in the absence of wall
motion abnormality. If regional dysfunction is present or the LV is compromised,
a quantitative ejection fraction would still be required.
II. Exclusion
Criteria
- Potential participant is currently prescribed
an ACE inhibitor which cannot be discontinued.
- Contraindication to the use of an ACE inhibitor
(e.g., prior adverse experience with an ACE inhibitor, current or planned
pregnancy, any angioedema, or hyperkalemia).
- Current clinical condition(s) requiring the use
of an ACE inhibitor (e.g., symptomatic congestive heart failure, hypertension
requiring ACE inhibitor for adequate control).
- Current clinical requirement for use of an
angiotensin II receptor antagonist.
- Hospitalization for unstable angina occurring
less than two months prior to the date of randomization.
- Valvular heart disease which, in the assessment
of the treating physician, is likely to require surgical intervention.
- Coronary artery bypass surgery within three
months prior to the date of randomization.
- Percutaneous transluminal coronary angioplasty
within three months prior to the date of randomization.
- Plans for elective coronary revascularization
procedure.
- Serum creatinine > 2.0 mg/dL (177
mol\L)(measured within 12 months prior to the date of randomization).
- Serum potassium > 5.5 mEq/L (5.5
mmol/L) from most recent laboratory assessment within 12 months prior to the
date of randomization.
- Other concurrent medical conditions thought
likely to limit five-year survival (e.g., certain cancers, cirrhosis, severe
chronic obstructive pulmonary disease).
- Psychosocial conditions not conducive to
adherence to the long-term requirements of this trial.
- Inability or unwillingness to provide written
informed consent.
- Women of childbearing potential not using
adequate contraception.
- Current use of non-FDA or non-HPB approve
medication in a research trial.
Treatment
Prior to the actual randomization, all
consenting eligible patients will be given a 20-day supply of trandolapril (2 mg
per day). After two weeks patients will return to the clinic and those who
experienced no adverse reactions and took 80% or more of the run-in supply will
be randomized to either trandolapril or a matching placebo at a dose of 2 mg per
day. Treatment will be increased at the 6-month visit. There is an equal chance
of being assigned to either arm of the study.
Follow-up
Patients are followed every six months until the
study ends in December 2003.
To request a list of PEACE centers
near you, please contact the PEACE Clinical and Statistical Coordinating
Center:
Clinical and Statistical
Coordinating Center
6110 Executive Boulevard, Suite 750
Rockville,
Maryland 20852
Phone: 1-800-793-8525
Fax: 1-800-526-4648
Email:
Cleary@biostat.bsc.gwu.edu
The NHLBI Project Office is responsible for the
overall direction and management of the study, monitors the progress of the
study, and provides organizational and scientific guidance. Dr. Yves Rosenberg,
the PEACE Project Officer may also be contacted for further information regarding PEACE:
National Heart, Lung and Blood
Institute
Two Rockledge Center
6701 Rockledge Drive
Bethesda, Maryland
20892-7936
Phone: 301-435-0399
Fax: 301-480-3667
Email:
RosenbeY@gwgate.nhlbi.nih.gov
