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Clinical Trials/CTRI/2011/08/001950
CTRI/2011/08/001950
Completed
N/A

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

STEMI India Charitable Trust0 sites200 target enrollmentTBD
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ConditionsHealth 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.

Overview

Phase
N/A
Intervention
Not specified
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.
Sponsor
STEMI India Charitable Trust
Enrollment
200
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Observational

Investigators

Sponsor
STEMI India Charitable Trust

Eligibility 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)
  • •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

  • •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

Outcomes

Primary Outcomes

Not specified

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