INVEST: INternational VErapamil SR Trandolapril STudy

This study has been completed.

Sponsor:

Collaborator:

Abbott

Information provided by (Responsible Party):

University of Florida

ClinicalTrials.gov Identifier:

NCT00133692

First received: August 22, 2005

Last updated: September 16, 2011

Last verified: August 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

August 22, 2005

Last Updated Date

September 16, 2011

Start Date ^ICMJE

September 1997

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

First occurrence of death or nonfatal myocardial infarction (MI) or nonfatal stroke

Original Primary Outcome Measures ^ICMJE

First ocurrence of Death or Nonfatal MI or Nonfatal Stroke

Change History

Complete list of historical versions of study NCT00133692 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Death
Nonfatal MI
Nonfatal stroke
Newly diagnosed diabetes
BP control
Cancer
GI Bleeding
Alzheimer's Disease
Parkinson's Disease
CV Hospitalizations
Quality of life
Compliance

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

INVEST: INternational VErapamil SR Trandolapril STudy

Official Title ^ICMJE

INternational VErapamil SR Trandolapril STudy

Brief Summary

Because blood pressure affects the heart, blood vessels, kidneys, and the entire body, it is important to keep it as normal as possible. There are several different ways to control blood pressure and to prevent or limit the development of heart disease due to high blood pressure. The purpose of this study is to compare two treatments to see how well they work and the difference in their side effects. One treatment includes the use of a calcium antagonist drug (Isoptin sustained release [SR] or Verapamil SR). The other treatment excludes the calcium antagonist and may include a non-calcium antagonist drug called a beta blocker (Tenormin or Atenolol). Both treatments may also include medication called angiotensin converting enzyme (ACE) inhibitors and water pills. None of the drugs in this study are experimental, they are all approved by the Food and Drug Administration (FDA).

Detailed Description

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 ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Hypertension
Coronary Artery Disease

Intervention ^ICMJE

Drug: Verapamil SR/Trandolapril/Hydrochlorothiazide (HCTZ)
Drug: Atenolol/HCTZ/Trandolapril

Study Arms

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

22000

Estimated Completion Date

February 2003

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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
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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

50 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00133692

Other Study ID Numbers ^ICMJE

INVEST

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

University of Florida

Study Sponsor ^ICMJE

University of Florida

Collaborators ^ICMJE

Abbott

Investigators ^ICMJE

Principal Investigator:

Carl J Pepine, MD

University of Florida

PRS Account

University of Florida

Verification Date

August 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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