drugset / Trial / NCT01396395

Research on Nicorandil Treatment of Patients Diagnosed as CHD (Coronary Heart Disease) With Stable Angina

NCT01396395 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

This study of 402 cases of stable angina subjects who were diagnosed as Coronary Heart Disease (CHD) is a randomized, blank controlled, multi-center clinical study. Subjects who are taking standard treatment with stable symptoms will receive a 24-hour ambulatory electrocardiogram (ECG) (Holter) examination. They will be randomly divided into two groups. The nicorandil group will receive nicorandil 5 milligram (mg) (3 times a day = tid) on top of the standard treatment for 12 weeks, while the control group will stay on standard treatment. Nitrates and beta blockers need to be maintained on a stable dose. Other drugs that do not affect the primary endpoint may be adjusted per investigators decision.

Timeline

Start
2011-09
Primary completion
2014-05
Completion
2014-05

Outcome

Met primary endpoint

registry Standard Treatment Plus Nicorandil vs Standard Treatment; p =0.0086; Ratio 0.503 (95% CI 0.301 to 0.840) NCT01396395 ↗

paper CONCLUSION: Nicorandil significantly reduced the number of ischemic attacks when added to standard antianginal treatment PMID 27657471 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Nicorandil Other / unclassified 5 mg Oral
Background Aspirin Small molecule — —