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
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Male or female subjects aged between 40 and 75 years (both inclusive).
- •2. 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.
- •3. Subjects with ability to understand and provide written informed consent form, which must have been obtained prior to screening.
- •4. Subjects willing to comply with the protocol requirements.
排除标准
- •1. Subjects who are being treated with agents inhibiting blood clotting if the agent cannot be stopped at study start.
- •2. Subjects who have planned coronary, cerebrovascular, or peripheral arterial Revascularization (invasive surgery) at study start.
- •3. Subjects with history of multi vessel coronary artery disease.
- •4. Subjects with history of bleeding disorders.
- •5. Subjects who need chronic oral anti-coagulant therapy or chronic low-molecular weight heparin.
- •6. Subjects with a history of ischemic stroke.
- •7. 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.
- •8. 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.
- •9. Subjects considered to be at risk of bradycardic events unless already treated with a permanent pacemaker.
- •10. Subjects who have had open heart surgery within the past 5 years, unless the person had a myocardial infarction after the surgery.
- •11. Subjects with clinically significant impaired hepatic function. [SGOT & SGPT more than 3X the UNL and/or Total bilirubin more than 1.5X the UNL].
- •12. Subjects with kidney failure requiring dialysis.
- •13. Subjects with known clinically important thrombocytopenia.
- •14. Female subjects who are pregnant or lactating or planning to become pregnant during the study period.
- •15. Females who are not ready to use acceptable contraceptive methods during the course of study.
- •16. Concurrent participation in another clinical trial or any investigational therapy within 90 days prior to signing informed consent.
- •17. Subjects with history of HIV and or Hepatitis B and or Hepatitis C.
- •18. Suspected inability or unwillingness to comply with the study procedures.
- •19. Subjects with clinically significant disorder that, in the opinion of the investigator, would result in jeopardizing patient’s safety and efficacy of the drug.
研究者
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