drugset / Trial / NCT01342029
Treatment With Ranolazine in Microvascular Coronary Dysfunction (MCD): Impact on Angina Myocardial Ischemia
RandomizedCrossoverDouble-blindTreatment
Summary
This research study is designed to test the use of ranolazine in patients with angina (chest discomfort due to reduced blood supply to the heart) due to microvascular coronary dysfunction (MCD; abnormalities in the small blood vessels of the heart). This drug is approved by the U.S. Food and Drug Administration (FDA) for treatment of chronic angina. The FDA has approved this drug based on studies primarily on patients with chronic angina with major blockages of the arteries.
Timeline
- Start
- 2011-05
- Primary completion
- 2016-12
- Completion
- 2016-12
Publications
- Rambarat CA, Elgendy IY, Handberg EM, Bairey Merz CN, Wei J, Minissian MB, Nelson MD, Thomson LEJ, Berman DS, Shaw LJ, Cook-Wiens G, Pepine CJ. Late sodium channel blockade improves angina and myocardial perfusion in patients with severe coronary microvascular dysfunction: Women's Ischemia Syndrome Evaluation-Coronary Vascular Dysfunction ancillary study. Int J Cardiol. 2019 Feb 1;276:8-13. doi: 10.1016/j.ijcard.2018.09.081. Epub 2018 Sep 26.
- Birkeland K, Khandwalla RM, Kedan I, Shufelt CL, Mehta PK, Minissian MB, Wei J, Handberg EM, Thomson LE, Berman DS, Petersen JW, Anderson RD, Cook-Wiens G, Pepine CJ, Bairey Merz CN. Daily Activity Measured With Wearable Technology as a Novel Measurement of Treatment Effect in Patients With Coronary Microvascular Dysfunction: Substudy of a Randomized Controlled Crossover Trial. JMIR Res Protoc. 2017 Dec 20;6(12):e255. doi: 10.2196/resprot.8057.
- Bairey Merz CN, Handberg EM, Shufelt CL, Mehta PK, Minissian MB, Wei J, Thomson LE, Berman DS, Shaw LJ, Petersen JW, Brown GH, Anderson RD, Shuster JJ, Cook-Wiens G, Rogatko A, Pepine CJ. A randomized, placebo-controlled trial of late Na current inhibition (ranolazine) in coronary microvascular dysfunction (CMD): impact on angina and myocardial perfusion reserve. Eur Heart J. 2016 May 14;37(19):1504-13. doi: 10.1093/eurheartj/ehv647. Epub 2015 Nov 27.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ranolazine | Small molecule | 500 mg | Oral |
| Subject | Ranolazine | Small molecule | 1000 mg | Oral |