Key result
Planned JCADII trial tests whether aggressive LDL-C and BP lowering reduces major events in CAD.
Why the study?
It has not been shown in Japanese patients with CAD if multiple aggressive medical interventions for coronary risk factors provide additional benefits compared with standard regimens.
RCT (n=500)
Open-label, blinded-endpoint
Randomized
Yes
Answers are grounded in this paper and cite their sources.
May support intensified multi-risk modification in Japanese CAD patients; leaves open whether aggressive regimens outperform standard care in prospective cohorts.
BACKGROUND: The benefits of coronary risk modification through medication and other methods have been shown in many clinical studies. Recently, aggressive lowering of low-density lipoprotein-cholesterol (LDL-C) has been shown to confer additive benefits in patients with coronary artery disease (CAD). However, it has not been shown in Japanese patients with CAD if multiple aggressive medical interventions for coronary risk factors are beneficial compared with standard regimens, so a prospective, randomized, open-label, blinded-endpoint (PROBE) multicenter study was designed to evaluate whether aggressive lowering of LDL-C and blood pressure in Japanese hypertensive, hypercholesterolemic CAD patients bestows additional benefits compared with regimens based on current Japanese guidelines. METHODS AND RESULTS: Seventeen hospitals in Japan are participating in the Japanese Coronary Artery Disease II (JCADII) study. Hypertensive and hypercholesterolemic patients who have >or=75% stenosis in at least one major coronary artery according to American Heart Association guidelines will be allocated randomly to receive either conventional or aggressive therapy. Standard therapy for hypertension and hypercholesterolemia aims to reduce blood pressure to <140/90 mmHg and LDL-C concentration to <100 mg/dl. Aggressive therapy aims for targets of <120/80 mmHg and <80 mg/dl, respectively. We plan to recruit 500 patients and follow them up for 3 years. Antihypertensive agents, when used, include the angiotensin receptor blockers candesartan and/or losartan. Antihypercholesterolemic agents, when used, include at least one of the following statins: pravastatin, simvastatin, and atorvastatin. CONCLUSION: The JCADII study will provide important information concerning medical treatment of coronary risk factors in Japanese patients with CAD (UMIN-ID: UMIN000000571).
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Nagai et al. (2007) conducted an RCT in Coronary Artery Disease with hypertension and hypercholesterolemia (n=500). Aggressive lowering of LDL-C and blood pressure vs. Conventional therapy (Target BP <140/90 mmHg, LDL-C <100 mg/dl) was evaluated on Composite of all deaths, non-fatal myocardial infarction, unstable angina pectoris, coronary artery bypass graft operation, non-fatal stroke, non-fatal major vascular diseases and peripheral artery diseases. The JCADII study is a planned randomized controlled trial designed to evaluate whether aggressive lowering of LDL-C and blood pressure reduces cardiovascular events in Japanese patients with coronary artery disease, with no results reported yet.
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