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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).

A prospective, observational, study of Pharmaco-invasive Strategy with Reteplase in Indian patients with STEMI - RePAMI

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2017/09/009796
Enrollment
200
Registered
2017-09-15
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- STEMI

Interventions

Intervention1: Thrombolysis and PCI: This is a pilot, prospective, observational, study to evaluate the efficacy and safety of a strategy of early fibrinolytic treatment with Reteplase (rPA) and addit

Sponsors

STEMI INDIA
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
To assess safety during the course of the study by means of monitoring treatment emergent adverse eventsTimepoint: 1.Death, Reinfarction, repeat revascularization 2.Failed thrombolysis/rescue PCI 3.Nonintracranial hemorrhage (total, major, minor and blood transfusions) 4.Intracranial hemorrhage 5.Others—

Countries

India

Contacts

Public ContactThomas Alexander

Kovai Medical Center and Hospital Ltd

tomalex41@gmail.com9791907685

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026