CTRI/2014/03/004442招募中1 期
Efficacy and Safety of Bolus Injection of a Novel Thrombolytic Agent (SMRX-11) in Patients with Acute ST-segment Elevation Myocardial Infarction (STEMI): A Phase II Open-Label, Dose-Escalation, Multicentre, Angiographic Trial - SMRX-11
Symmetrix Biotech Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
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.Patient with acute ST Segment Elevation Myocardial Infarction (STEMI). ST segment elevation of at least 2 mm in 2 or more contiguous leads without LBBB, stroke or LVH (left ventricular hypertrophy).
- •2.Patients aged more than 18 and less 65 years old.
- •3.Patient has persistent ischemic chest pain lasting for more than equal to 30 minutes.
- •4.Patient has symptom duration less than 6 hours
- •5.Patient has no contraindications to thrombolytic therapy
- •6.Patients willing to adhere to the protocol requirements and to provide written informed consent.
排除标准
- •a. Related to study methodology
- •1.Has a history of hypersensitivity or allergies to similar class of drug as the study drug.
- •2.Has high probability of being unavailable for 30 day/1 year follow-up
- •3.Has age 18 years or 65 years
- •4.Female patients having pregnancy (positive urine pregnancy test) or, parturition within the previous 30 days, or with childbearing potential not using adequate contraception.
- •5.Female patients currently breast feeding.
- •6.Patient is an investigator, co-investigator, research staff or a relative thereof involved in the conduct of the trial.
- •7.Use of other investigational agents or devices within 30 days prior to enrollment in the study.
- •8.Inability to undergo cardiac catheterization.
- •9.History or presence of current cocaine abuse.
- •10.History or presence of active cancer or active infection.
- •11.Difficulty with donating blood.
- •12.Major illness during 3 months before screening.
- •13.Participation in a drug research study within past 3 months.
- •14.Donation of blood in the past 3 months before screening.
- •15.Symmetrix or company employees or investigator site personnel directly affiliated with this study, and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted.
- •Cardiovascular
- •1.Patient treated with any thrombolytic agent within the preceding month (with conventional streptokinase or APSAC within preceeding 12 months) for Acute Myocardial Infarction or any other thrombosis-related indication.
- •2.Previous history of Coronary Artery Bypass Grafting surgery (CABG) / previous Percutaneous Coronary Intervention (PCI).
- •3.Cardiogenic shock (eg. BP less than 90 mmHg with IV vasopressors or less than 80 mmHg without IV vasopressors).
- •4.History or presence of atrial fibrillation or atrial flutter.
- •5.LBBB new or old (difficulty in diagnosing STEMI and assessing ST resolution).
- •6.LVH (Left Ventricular Hypertrophy) by voltage criteria.
- •b. Related to prior or concomitant treatments
- •1.Current use of oral anticoagulants (e.g. Coumadin), parental anticoagulants (.g. unfractionated or low molecular weight heparins) and thrombolytic agents.
- •2.Previous use of streptokinase within 12 months.
- •3.Use of GPIIb/IIIa inhibitors or P2Y12 inhibitors within 1 week of enrollment into the study.
- •4.Patient having a known allergy to aspirin.
- •c. Related to current knowledge about conventional Streptokinase and SMRX-11
- •1.History of prior intracranial hemorrhage.
- •2.History or presence known structural cerebral vascular lesion (e.g., AVM- Arterio-venous malformation).
- •3.Patient has known malignant intracranial neoplasm (primary or metastatic).
- •4.Has suspected aortic dissection.
- •5.History or presence of active bleeding or bleeding diathesis (excluding menses).
- •6.Significant closed head trauma or facial trauma within 3 months.
- •7.History or presence of chronic, severe, poorly controlled hypertension.
- •8.Patients with severe and uncontrolled hypertension on presentation (SBP more than 180 mm Hg or DBP more than 110mmHg).
- •9.History of prior ischemic stroke more than 3 months, dementia, or known intracranial pathol
研究者
相似试验
尚未招募
Unknown
A clinical trial to Evaluate safety and efficacy of bolus dose versus fractional dose of injection hyperbaric ropivacaine (0.75%) in subarachnoid block for patients undergoing Gynaecological surgery.CTRI/2024/07/071068Kevin Dobariya
招募中
3 期
A clinical trial to study the effects of mumps-measles-rubella vaccine in improving patients with multiple warts in skiCTRI/2017/10/010021Dr Prof Shyam Sundar Chaudhary
尚未招募
3 期
role of injectable platelet rich fibrin in periodontal diseasesCTRI/2023/09/057296TEPARAMESWARI
已完成
不适用
Safety and efficacy of new pressure type infusion instrument VESSEL FUSER (type T) in outpatient cases with colon cancer for home anti-cancer chemotherapycolon cancerJPRN-UMIN000026054Kobe City Medical center General Hospital40
招募中
1 期
Investigating the effect of stromal/mesenchymal stem cell-derived exosomes in patients with perianal fistulaAnal fistulaIRCT20240128060828N1Tehran University of Medical Sciences30