A New formulation of drug for Heart Attack and Comparison with Pre-existing drug

Comparison of clinical outcomes between patients with Acute Coronary Syndrome receiving Conventional Loading Dose and Newly formulated loading dose with Trimetazidine - NIL

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/11/077130

Enrollment

Registered

2024-11-20

Start date

Unknown

Completion date

Unknown

Last updated

2024-12-09

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

Conditions

Health Condition 1: I219- Acute myocardial infarction, unspecified

Interventions

Intervention1: New formulation of Loading dose: New formulation of Loading dose for Acute Coronary Syndrome containing Aspirin(300mg), Clopidogrel(300mg), Atorvastatin(80mg), Trimetazidine(35mg) Contr

Eligibility

Inclusion criteria

Inclusion criteria: 1. Ability to consent 2. Patients presenting with symptoms suggestive of ACS, including chest pain or discomfort, and corresponding ECG changes indicative of ischemia or myocardial injury (ST-segment elevation, ST-segment depression, T-wave inversion). 3. Absence of contraindications to aspirin, clopidogrel, statins, and Trimetazidine, including known allergies, intolerances, or significant adverse reactions. 4. Hemodynamically stable patients, defined as those without evidence of ongoing ischemia or hemodynamic compromise requiring urgent intervention (e.g., cardiogenic shock).

Exclusion criteria

Exclusion criteria: 1. Age above 80 years 2. Inability to consent 3. Patients with a recent history of major bleeding events within a specified time frame, typically within the past 30 days, increasing the risk of recurrent bleeding complications with antiplatelet and anticoagulant therapy. 4. Patients presenting with hemodynamic instability requiring immediate revascularization or intensive care management, such as cardiogenic shock or acute pulmonary edema. 5. Patients with symptoms suggestive of chest pain or discomfort due to non-cardiac causes (e.g., musculoskeletal pain, gastrointestinal disorders) without evidence of ACS on diagnostic evaluation.

Design outcomes

Primary

Measure	Time frame
Estimation of Major Adverse Cardiac Events using Seattle Angina ScoreTimepoint: 1 month after administration of drug	—

Secondary

Measure	Time frame
Quality of Life, Mortality due to Cardiac Cause, Number of hospital visits, Duration and the Number of Hospital admissionTimepoint: 3 months after administration of drug	—

Countries

India

Contacts

Public ContactDR SAI SINDHURI MARUVADA

SAVEETHA MEDICAL COLLEGE AND HOSPITAL

sindhu.1903@gmail.com07382990519

Outcome results

None listed

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