To evaluate the efficacy and safety assessment of Nicorandil in ASCVD with Angina
- Conditions
- Health Condition 1: I709- Other and unspecified atherosclerosis
- Registration Number
- CTRI/2024/01/061624
- Lead Sponsor
- Torrent Pharmaceutical Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Male or female patients more than 18 years of age
Stable CAD cases with effort or exertional Angina
Stable CAD with effort Angina who have undergone CCTA or Angiography to delineate coronary anatomy for non obstructive CAD
Trop T more than 0 point 07 nano gram per ml and ECG changes with ST deviation more than 0 point 05 mV that require PCI
Unstable or uncontrolled cases of CAD with Hypertension or signs of acute MI with blood pressure less than 100mmhg
Cardiac shock
Aortic dissection
History of myocardial infarction or percutaneous coronary intervention or coronary artery bypass grafting less than 1 month
Contraindicated or intolerable to nicorandil
Patients on background use of Long acting nitrates
Pregnant or lactation period
Patients with an estimated survival time of less than 1 year
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Canadian Cardiovascular Society CCS Angina score <br/ ><br>Timepoint: 4 week and 12 week
- Secondary Outcome Measures
Name Time Method Change in Angina frequency at 12 W <br/ ><br> <br/ ><br>Change in impact on QoL at 12W <br/ ><br> <br/ ><br>Rescue medication use with sublingual Nitroglycerin at 12W <br/ ><br> <br/ ><br>Safety assessments in terms of AEs at 12WTimepoint: Follow up at 12 weeks <br/ ><br> <br/ ><br>Follow Up at 12 weeks <br/ ><br> <br/ ><br>Follow up at 12 weeks <br/ ><br> <br/ ><br>Follow Up at 12 weeks