Comparison of clinical outcomes between patients with Acute Coronary Syndrome receiving Conventional Loading Dose and Newly formulated loading dose with Trimetazidine
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Estimation of Major Adverse Cardiac Events using Seattle Angina Score
研究概览
简要总结
This study involves pharmacological development of oral formulation in the form of tablet with Acetyl Salicylic acid(300mg), Clopidogrel(300mg), Atorvastatin(80mg) and Trimetazidine(35mg). Following the development of the composition, Preclinical animal trial will be conducted for a period of 30 days, to assess the adverse drug reactions (ADR) of the newly developed formulation. Phase-1 clinical trial will be conducted in healthy volunteers, by administering newly developed formulation. Regular monitoring of vital signs (Heart rate, blood pressure, temperature), regular blood and urine test (Liver and kidney function test) to look for signs of toxicity will be done. Participants will be closely monitored for any adverse effects. Phase-2 clinical trial: Participants who satisfy the inclusion criteria will be randomly assigned to either of the two groups, one group receiving the Newly developed formulation and the other group receiving Conventional loading dose. To compare the efficacy of the formulation MACE(Major Adverse Cardiovascular Events), Quality of Life(Seattle Angina Questionnaire) will be assessed over 3 months duration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Ability to consent
- •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).
- •Absence of contraindications to aspirin, clopidogrel, statins, and Trimetazidine, including known allergies, intolerances, or significant adverse reactions.
- •Hemodynamically stable patients, defined as those without evidence of ongoing ischemia or hemodynamic compromise requiring urgent intervention (e.g., cardiogenic shock).
排除标准
- •Age above 80 years
- •Inability to consent
- •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.
- •Patients presenting with hemodynamic instability requiring immediate revascularization or intensive care management, such as cardiogenic shock or acute pulmonary edema.
- •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.
结局指标
主要结局
Estimation of Major Adverse Cardiac Events using Seattle Angina Score
时间窗: 1 month after administration of drug
次要结局
- Quality of Life, Mortality due to Cardiac Cause, Number of hospital visits, Duration and the Number of Hospital admission(3 months after administration of drug)
研究者
DR SAI SINDHURI MARUVADA
SAVEETHA MEDICAL COLLEGE AND HOSPITAL