CTRI/2020/03/023925Not Applicable3 期
"A Multicentric, Randomized, Open Label, Parallel Group, Comparative, Phase III Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Ticagrelor SR Tablets Versus Ticagrelor Tablets on a Background of Aspirin Therapy in Patients with the History of Myocardial Infarction."
试验速览
- 阶段
- 3 期
- 状态
- Not Applicable
- 入组人数
- 320
- 试验地点
- 12
- 主要终点
- Any event after randomization from the composite of cardiovascular death, non-fatal MI, or non-fatal stroke.
研究概览
简要总结
“A Multicentric, Randomized, Open Label, ParallelGroup, Comparative, Phase III Clinical Study to Evaluate the Efficacy, Safetyand Tolerability of Ticagrelor SR Tablets Versus Ticagrelor Tablets on aBackground of Aspirin Therapy in Patients with the History of MyocardialInfarction.â€
Primary objective:
To evaluate theefficacy and safety of Ticagrelor SR Tablets Versus Ticagrelor Tablets on aBackground of Aspirin Therapy in Patients with the History of MyocardialInfarction.
Secondary objective:
To evaluate thetolerability of Ticagrelor SR Tablets Versus Ticagrelor Tablets on a Backgroundof Aspirin Therapy in Patients with the History of Myocardial Infarction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 40.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female subjects aged between 40 and 75 years (both inclusive).
- •Subjects who are currently on the treatment of Ticagrelor Tablets 90 mg twice daily or 60 mg twice daily from at least 3 months with the history of myocardial infarction.
- •Subjects with ability to understand and provide written informed consent form, which must have been obtained prior to screening.
- •Subjects willing to comply with the protocol requirements.
排除标准
- •Subjects who are being treated with agents inhibiting blood clotting if the agent cannot be stopped at study start.
- •Subjects who have planned coronary, cerebrovascular, or peripheral arterial Revascularization (invasive surgery) at study start.
- •Subjects with history of multi vessel coronary artery disease.
- •Subjects with history of bleeding disorders.
- •Subjects who need chronic oral anti-coagulant therapy or chronic low-molecular weight heparin.
- •Subjects with a history of ischemic stroke.
- •Subjects with a history of intracranial bleeding at any time, a tumor or blood vessel abnormality in the brain and/or spinal cord at any time, a history of surgery involving the brain or spinal cord within the last 5 years.
- •Subjects with a history of bleeding from the gastrointestinal tract (e.g., esophagus, stomach, colon, rectum) within the last 6 months or a major surgery within the last 30 days.
- •Subjects considered to be at risk of bradycardic events unless already treated with a permanent pacemaker.
- •Subjects who have had open heart surgery within the past 5 years, unless the person had a myocardial infarction after the surgery.
- •Subjects with clinically significant impaired hepatic function.
- •[SGOT & SGPT more than 3X the UNL and/or Total bilirubin more than 1.5X the UNL].
- •Subjects with kidney failure requiring dialysis.
- •Subjects with known clinically important thrombocytopenia.
- •Female subjects who are pregnant or lactating or planning to become pregnant during the study period.
- •Females who are not ready to use acceptable contraceptive methods during the course of study.
- •Concurrent participation in another clinical trial or any investigational therapy within 90 days prior to signing informed consent.
- •Subjects with history of HIV and or Hepatitis B and or Hepatitis C.
- •Suspected inability or unwillingness to comply with the study procedures.
- •Subjects with clinically significant disorder that, in the opinion of the investigator, would result in jeopardizing patient’s safety and efficacy of the drug.
结局指标
主要结局
Any event after randomization from the composite of cardiovascular death, non-fatal MI, or non-fatal stroke.
时间窗: At Week 1, Week 2, Week 4, Week 8, Week 12, Week 18 and Week 24
次要结局
- The assessment of safety of subjects [comparison of incidence of treatment emergent adverse event (TEAE)].(At Week 1, Week 2, Week 4, Week 8, Week 12, Week 18 and Week 24)
研究者
研究点 (12)
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