A Pilot Study Exploring Efficacy and Safety of Amlodipine in the Stented Angina Patients

Seoul National University

Status and phase: Unknown; Phase 4

Conditions: Coronary Artery Disease

Treatments: Drug: Amlodipine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01120327

Amlodipine study

Details and patient eligibility

About

1. OBJECTIVES

   Primary objective to evaluate the difference of the peak oxygen uptake change (VO2 max, mL/kg/min) in amlodipine group against no CCB group at 9 months

   Secondary objectives To evaluate the change of sublingual nitrate use per day against no CCB group at 1 and 3 months To evaluate the change of biomarkers against no CCB group at 9 months

2. SUBJECTS AND CENTERS 212, stable angina patients with angiographically confirmed significant residual stenosis 10, 3rd-grade, teaching hospitals in Korea

Enrollment: 212 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Stable angina patient with angiographically confirmed significant residual stenosis
• Stenosis more than 50% in 2 major coronary arteries at least or Stenosis more than 75% in 1 major coronary artery

Exclusion criteria

• No other pulmonary/psychiatry/musculoskeletal disorder limiting CPET
• Contraindicated to the CPET (e.g. unstable angina, aortic stenosis, uncontrolled hypertension, uncontrolled asthma, hypoxemia at rest, epilepsy, locomotor disorder, severe hypertension and febrile illness)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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212 participants in 2 patient groups, including a placebo group

Amlodipine

Experimental group

Description:

Amlodipine

Treatment:

Drug: Amlodipine

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo