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To evaluate the efficacy and safety assessment of Nicorandil in ASCVD with Angina

Post-approval observational Study to assess Clinical Effectiveness and Safety of Nicorandil as initial- line adjuvant therapy in MVA and ANOCA - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/01/061624
Enrollment
100
Registered
2024-01-19
Start date
Unknown
Completion date
Unknown
Last updated
2024-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I709- Other and unspecified atherosclerosis

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Torrent Pharmaceutical Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Change in Canadian Cardiovascular Society CCS Angina score Timepoint: 4 week and 12 week

Secondary

MeasureTime frame
Change in Angina frequency at 12 W Change in impact on QoL at 12W Rescue medication use with sublingual Nitroglycerin at 12W Safety assessments in terms of AEs at 12WTimepoint: Follow up at 12 weeks Follow Up at 12 weeks Follow up at 12 weeks Follow Up at 12 weeks

Countries

India

Contacts

Public ContactDr Krishna prasad K

Sawhney Heart Centre Delhi

jpssawhney@yahoo.com9810059773

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026