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To check safety of nicorandil medicine in heart disease patient

Investigator initiated Post approvaL observational Study to assess Clinical efficacy and safety of NicorandIl as initial line therapy In ACS and Type 2 MI cases - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/11/060118
Enrollment
100
Registered
2023-11-22
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

Health Condition 1: I228- Subsequent ST elevation (STEMI) myocardial infarction of other sites

Interventions

Intervention1: NIL: NIL Intervention2: nil: nil Control Intervention1: nil: nil

Sponsors

Torrent Pharmaceuticals
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Male Or Female Patients More Than 18 years Of Age Cases Of ACS NSTEMI STEMI or Unstable Angina with Multivessel Disease And SYNTAX score is less then 35 Requiring Revascularization Or PCI OR Cases of ACS and Type 2 MI With The Presence of Non Obstructive Coronary Artery On Angiography Defined As No Coronary Artery Stenosis 50 percentage In Any Potential Infarct related Artery

Exclusion criteria

Exclusion criteria: Cases With persistent Systolic Blood pressure Less Than 100mmhg Following Revascularization Cardiac shock Aortic Dissection History Of Myocardial Infarction Or Percutaneous Coronary Intervention Or Coronary Artery Bypass Grafting Less than 1 Month Cases Requiring Addon Nicorandil Inj To Intravenous Nitrates Before Percutaneous Coronary Intervention Contraindicated Or Intolerable To Nicorandil Pregnant Or Lactation Period Patients With An Estimated Survival Time Of Less Than 1 year

Design outcomes

Primary

MeasureTime frame
Rate of slow re flow or no reflow Time Frame 3 minutes after primary PCI final coronary flow in the culprit artery Rate of complete or more than 50 percent ST segment resolution on ECG Time Frame 2 hours after primary PCITimepoint: Followup after 3 minutes of PCI Followup after 2 hour of primary PCI

Secondary

MeasureTime frame
Cardiac Troponin I(cTnI)and CK MB levels at 72 hour Percent cases with persistent angina or pain despite revascularization PCI at 4and 12 week with no collateral artery closure or embolization Safety assessments in terms of AEs at 12week Rate of slow or no-reflow for the subgroups withT2Dor polyvascular or diffuse disease or smokersTimepoint: Followup at 72 hours Followup at 4 weeks 12 weeks Followup at 12 weeks

Countries

India

Contacts

Public ContactDr Krishnaprasad K

Apollo CVHF Heart institute

drsameerdani@gmail.com9825038855

Outcome results

None listed

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