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International nifedipine trial on antiatherosclerotic therapy (INTACT)
P R Lichtlen1, U Nellessen, W Rafflenbeul
1Department of Cardiology, Hannover Medical School, FRG.
Abstract:
A number of animal studies revealed an inhibition or retardation of the progression of atherosclerosis by calcium-antagonists. Encouraged by these studies, a multicenter trial on the progression of coronary artery disease (CAD) in man was initiated testing the antisclerotic effect of nifedipine against placebo in 426 patients with mild to moderate coronary disease over 3 years. All patients underwent coronary angiography before entering the trial and will be restudied after 3 years; changes of the coronary artery lumen size are quantitatively assessed by a computer-assisted system (CAAS). INTACT (International Trial on Antiatherosclerotic Coronary Therapy) is therefore the first randomized prospective study on the progression of CAD based on a quantitated anigraphic control of the coronary system. This report presents the design of this still-ongoing study as well as inclusion and exclusion criteria. The quantitative evaluation of the coronary angiograms and the mode of compliance test are described in detail. A number of baseline data as well as the preliminary results of the quantitative evaluation of the first coronary angiograms are presented. Beside the results on the effect of the calcium-antagonist nifedipine on the progression of CAD, INTACT might also supply information on the antiatherosclerotic potency of other drugs administered additionally (beta-blockers and nitrates) and of HDL-cholesterol.
Insights
Calcium antagonists like nifedipine may slow atherosclerosis progression in coronary artery disease (CAD). The INTACT trial investigates this effect in patients using quantitative coronary angiography over three years.
Area of Science:
- Cardiology
- Pharmacology
- Medical Research
Background:
- Animal studies suggest calcium antagonists inhibit atherosclerosis.
- This prompted a human trial to test the anti-atherosclerotic effects of nifedipine.
Purpose of the Study:
- To evaluate the effect of nifedipine on coronary artery disease (CAD) progression.
- To serve as the first randomized prospective study on CAD progression with quantitative angiographic control.
Main Methods:
- A multicenter trial involving 426 patients with mild to moderate CAD.
- Quantitative coronary angiography assessed lumen size changes over 3 years using a computer-assisted system (CAAS).
- The study is randomized and placebo-controlled.
Main Results:
- Presents the study design, inclusion/exclusion criteria, and quantitative evaluation methods.
- Details compliance testing and presents baseline data.
- Preliminary results from quantitative evaluation of initial coronary angiograms are included.
Conclusions:
- The INTACT trial is a novel randomized study for assessing CAD progression.
- It provides quantitative assessment of coronary artery lumen changes.
- Potential insights into other drugs (beta-blockers, nitrates) and HDL-cholesterol's antiatherosclerotic effects.