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An observational multicenter study comparing Tenecteplase assisted Percutaneous Coronary Intervention (PCI) versus primary PCI in Indian patients with ST elevation Myocardial Infarction

A prospective, observational, multicenter study comparing Tenecteplase facilitated PCI versus primary PCI in Indian patients with STEMI - STEPPAMI

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2011/08/001950
Enrollment
200
Registered
2011-08-16
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- Patients with acute STEMI who are to be treated with primary PCI/pharmacoinvasive therapy within 12 hours of symptoms onset will be included.

Interventions

Intervention1: facilitated Percutaneous coronary intervention: Early fibrinolytic treatment with Tenecteplase (TNK) and additional antiplatelet and antithrombin therapy followed by catheterization wit

Sponsors

STEMI India Charitable Trust
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients included in the study should satisfy the following criteria. 1.Adults 18 to 75 years of age complaining of chest pain, discomfort and/or indications of STEMI requiring either primary PCI or tenecteplase facilitated PCI will be included in the study. 2.Patients presenting with the onset of symptoms within 12 hours. 3.ECG including right ventricular leads (V4R) indicative of an acute STEMI (ST elevation will be measured from the J point scale; 1 mm per 0.1 mV greater than or equal to 2 mm ST elevation across 2 contiguous precordial leads (V1-V6) or leads I and aVL for a minimum combined total of greater than or equal to 4 mm ST elevation) OR Greater than or equal to 3mm ST elevation in 2 contiguous inferior leads (II, III, aVF) for a minimum combined total of greater than or equal to 6 mm ST elevation. 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: Patients meeting any of the following criteria will not be enrolled into the study. 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
Following are the Primary Endpoints: Death and reinfarction Death maybe due to cardio vascular and non-cardio vascular reasons. Death due to cardio vascular reasons may include: 1)Reinfarction 2)Cardiogenic Shock 3)Cardiac failure Death due to non cardio vascular reasons may include 1)Procedure related injury 2)Others Timepoint: Nil

Secondary

MeasureTime frame
Following are the Secondary Endpoints: 1)Nonintracranial hemorrhage (total, major, minor and blood transfusions) 2)Intracranial hemorrhage Timepoint: Nil

Countries

India

Contacts

Public ContactMullasari Ajit sankardas

Kovai Medical Center and Hospital

tomalex41@gmail.com

Outcome results

None listed

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