Prospective, multi-centric, open label, two arm, parallel group, active control, randomized, comparative clinical study to evaluate efficacy and safety of R-TPR-019 / ReoProÂ® in subjects undergoing percutaneous coronary intervention

Reliance Life Sciences Pvt Ltd0 个研究点目标入组 104 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1 Patients undergoing urgent or elective PCI for the prevention of cardiac ischemic complications
•2 Women of child bearing potential having a negative pregnancy test and taking adequate birth control measures
•3 Consent from Legally Acceptable Representative (LAR), if subject is not in the condition to give consent. However, when the subject is stable and is able to give consent, consent would be obtained on a separate ICF to confirm his/her willingness to continue in the study

•1 Administration of oral anticoagulants within 7 days unless prothrombin time is less than or equal to 1.2 times control, thrombocytopenia ( <100,000 cells/TL).
•2 Intracranial neoplasm, Arteriovenous malformation or aneurysm.
•3 Presumed or documented history of vasculitis
•4 Use of intravenous dextran before percutaneous coronary intervention, or intent to use it during intervention
•5 CABG or PCI procedure in past history involving the infarct-related artery.
•6 Participation in another study with any investigational drug or device within the previous 30 days.
•7 Concomitant non-cardiac disease likely to limit long-term prognosis (e.g. cancer).
•8 Previous administration of thrombolytics within 7 days.
•9 Intolerance or contraindications to acetyl Salicylic Acid.
•10 Previous hemorrhagic stroke.
•11 Previous ischemic cerebrovascular event within 3 months.
•12 Recent major surgery at risk of bleeding.
•13 Episodes of uncontrolled hypertension ( >180/110 mmHg despite treatment) in past 2 years.
•14 Pregnant and lactating females.

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