INternational VErapamil SR Trandolapril STudy
INVEST is an investigator initiated international, prospective, randomized study comparing
two pharmacotherapy strategies to control hypertension in ambulatory patients with coronary
artery disease (CAD). One strategy, the calcium antagonist care strategy, centers on a
calcium antagonist (verapamil SR) followed by addition of an ACE inhibitor (trandolapril)
and then diuretic (hydrochlorothiazide) as needed to achieve target blood pressures (BP).
The other strategy, the non-calcium antagonist care strategy, uses a beta-blocker (atenolol)
followed by addition of low-dose diuretic and then an ACE inhibitor (trandolapril) as needed
to reach target BP. In either strategy additional drugs can be added provided the calcium
antagonist is retained in the calcium antagonist care strategy and calcium antagonists are
omitted in the non-calcium antagonist care strategy.
The study is organized into 15 international regions with about 1,500 study investigators
randomizing approximately 22,000 patients who will be treated for at least two years. The
primary response variable is the occurrence of adverse outcome, defined as any of the
following events: all cause mortality, nonfatal MI or nonfatal stroke. A number of secondary
response variables, including newly diagnosed diabetes will also be evaluated.
The primary objective of this trial is to examine the hypothesis that the risk for adverse
outcomes (all cause mortality, nonfatal MI or nonfatal stroke) in hypertensive patients with
CAD is at least equivalent during treatment of hypertension with a calcium antagonist
strategy when compared with a non-calcium antagonist strategy.
Unique features of INVEST are, in addition to its size and international scope, its design
to mimic standard clinical practice and its all electronic online data entry, drug
distribution system, study management system, and electronic physician compensation. This
system will permit the entire trial to be conducted via the Internet. This design is
believed to be a forerunner of clinical trials research for the future.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
First occurrence of death or nonfatal myocardial infarction (MI) or nonfatal stroke
Carl J Pepine, MD
University of Florida
United States: Institutional Review Board
|University of Florida||Gainesville, Florida 32610-0277|