INVEST: INternational VErapamil SR Trandolapril STudy
|ClinicalTrials.gov Identifier: NCT00133692|
Recruitment Status : Completed
First Posted : August 23, 2005
Last Update Posted : September 20, 2011
|Condition or disease||Intervention/treatment||Phase|
|Hypertension Coronary Artery Disease||Drug: Verapamil SR/Trandolapril/Hydrochlorothiazide (HCTZ) Drug: Atenolol/HCTZ/Trandolapril||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||22000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||INternational VErapamil SR Trandolapril STudy|
|Study Start Date :||September 1997|
|Study Completion Date :||February 2003|
- First occurrence of death or nonfatal myocardial infarction (MI) or nonfatal stroke
- Nonfatal MI
- Nonfatal stroke
- Newly diagnosed diabetes
- BP control
- Gastrointestinal (GI) bleeding
- Alzheimer's Disease
- Parkinson's Disease
- Cardiovascular (CV) hospitalizations
- Quality of life
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00133692
|United States, Florida|
|University of Florida|
|Gainesville, Florida, United States, 32610-0277|
|Principal Investigator:||Carl J Pepine, MD||University of Florida|