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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
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date  ICMJE August 22, 2005
First Posted Date  ICMJE August 23, 2005
Last Update Posted Date September 20, 2011
Study Start Date  ICMJE September 1997
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2005)
First occurrence of death or nonfatal myocardial infarction (MI) or nonfatal stroke
Original Primary Outcome Measures  ICMJE
 (submitted: August 22, 2005)
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
 (submitted: October 31, 2005)
  • 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
 (submitted: August 22, 2005)
  • 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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE 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  ICMJE 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
 (submitted: August 22, 2005)
22000
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE 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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
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  ICMJE 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