This study is being conducted to evaluate the safety and efficacy of a strategy of early fibrinolytic treatment with Reteplase (rPA) in patients with ST- segment elevation myocardial infarction (STEMI).
- Conditions
- Health Condition 1: null- STEMI
- Registration Number
- CTRI/2017/09/009796
- Lead Sponsor
- STEMI INDIA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 200
1.Adults 18 to 75 years of age complaining of chest pain, discomfort and/or indications of STEMI requiring either primary PCI or pharmaco-invasive treatment with Reteplace will be included in the study.
2.Patients presenting with the onset of symptoms within 12 hours.
3.ST elevation New ST elevation at the J point in two contiguous leads with the cut-points: > 0.1 mV in all leads other than leads V2â??V3 where the following cut points apply: > 0.2 mV in men > 40 years; > 0.25 mV in men < 40 years, or > 0.15 mV in women.
4.Subjects / LAR or impartial witness (if applicable) must be able to understand and provide their consent in the informed consent form
1.Previous enrollment in this study or treatment with the investigational drug or participating in any other study in the past 30 days
2.Patients who are unwilling to participate in the study or sign the informed consent
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the efficacy of prompt fibrinolysis with rPA coupled with contemporary antiplatelet and antithrombotic therapy at first medical contact followed by timely catheterization or rescue coronary intervention in STEMI patients within 12 hours of symptom onset by IRA patency.Timepoint: Angiographic patency of Infarct related artery (IRA)
- Secondary Outcome Measures
Name Time Method To assess safety during the course of the study by means of monitoring treatment emergent adverse eventsTimepoint: 1.Death, Reinfarction, repeat revascularization <br/ ><br>2.Failed thrombolysis/rescue PCI <br/ ><br>3.Nonintracranial hemorrhage (total, major, minor and blood transfusions) <br/ ><br>4.Intracranial hemorrhage <br/ ><br>5.Others <br/ ><br>