INVEST: INternational VErapamil SR Trandolapril STudy
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ClinicalTrials.gov Identifier: NCT00133692 |
Recruitment Status :
Completed
First Posted : August 23, 2005
Last Update Posted : September 20, 2011
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Condition or disease | Intervention/treatment | Phase |
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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 |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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
- Death
- Nonfatal MI
- Nonfatal stroke
- Newly diagnosed diabetes
- BP control
- Cancer
- Gastrointestinal (GI) bleeding
- Alzheimer's Disease
- Parkinson's Disease
- Cardiovascular (CV) hospitalizations
- Quality of life
- Compliance

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Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female
- Age 50 to no upper limit
- Hypertension documented according to the 6th report of the Joint National Committee on Detection and Evaluation of the treatment of high BP (JNC VI) and the need for drug therapy (previously documented hypertension in patients currently taking antihypertensive agents is acceptable)
- Documented CAD (e.g., classic angina pectoris (stable angina pectoris; Heberden angina pectoris), myocardial infarction three or more months ago, abnormal coronary angiography, or concordant abnormalities on two different types of stress tests)
- Willingness to sign informed consent
Exclusion Criteria:
- Unstable angina, angioplasty, coronary artery bypass graft surgery (CABG) or stroke within one month. Patients taking beta blockers after myocardial infarction are excluded if study enrollment is planned within 12 months of myocardial infarction. No time limitation if not taking beta-blocker.
- Use of a ß-blocker within past two weeks
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Patients without a pacemaker and any of the following:
- Sinus bradycardia (< 50 beats/min.)
- Sick sinus syndrome
- Atrioventricular (AV)-block of more than 1st degree
- Documented contraindication to verapamil; documented contraindication to both atenolol and hydrochlorothiazide
- Atrial fibrillation/flutter with Wolff-Parkinson-White (WPW)-Syndrome
- Severe heart failure (New York Heart Association [NYHA] IV).
- Concomitant illnesses (e.g., severe renal failure [Serum creatinine ≥4.0 mg/dl], severe hepatic failure or known cirrhosis, etc.) which may affect outcome variables or where life expectancy is two years or less or which are likely to require frequent hospitalizations and/or treatment adjustments.
- Patients with psychiatric, cognitive, or social (e.g., alcoholism, etc.) conditions that would interfere with giving consent or cooperating or remaining available for follow-up for two years.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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 |
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University of Florida |
ClinicalTrials.gov Identifier: | NCT00133692 |
Other Study ID Numbers: |
INVEST |
First Posted: | August 23, 2005 Key Record Dates |
Last Update Posted: | September 20, 2011 |
Last Verified: | August 2010 |
Hypertension Coronary Artery Disease INVEST Diabetes |
Verapamil SR Trandolapril Atenolol HCTZ |
Hypertension Coronary Artery Disease Myocardial Ischemia Coronary Disease Vascular Diseases Cardiovascular Diseases Heart Diseases Arteriosclerosis Arterial Occlusive Diseases Atenolol Verapamil Hydrochlorothiazide Trandolapril Antihypertensive Agents Diuretics |
Natriuretic Agents Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Anti-Arrhythmia Agents Sympatholytics Autonomic Agents Peripheral Nervous System Agents Adrenergic beta-1 Receptor Antagonists Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Calcium Channel Blockers |