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).

Recruiting

• Conditions: STEMI

• Registration Number: CTRI/2017/09/009796
• Lead Sponsor: STEMI INDIA

Brief Summary

Acute coronary  syndrome is one of the leading causes of morbidity in India. Indians also show higher incidence of hospitalisation, morbidity, and mortality than other ethnic groups1.Current strategies of thrombolysis and PCI are well established interventions that are generally viewed as alternative approaches to restore coronary circulation.Standard primary PCI is superior to lytic therapy, provided it can be performed shortly after the first medical contact and by an experienced team. The ideal scenario of pre-hospital management of a patient with symptoms compatible with STEMI is as follows:

Ambulance called

Diagnosis made

Catheterization laboratory at PCI-capable facility notified

Unfortunately, in many parts of the world, patients are taken by ambulance or by private transportation- to a non-PCI-capable center. In those cases, inter-hospital transfer to a PCI-capable center is desirable, provided that PCI can be performed within 90-120 minutes after the first medical contact. Importantly, the PCI-capable center should be open 24 hours a day, 7 days a week.

Real world data also suggests that the door to balloon time to begin PCI as suggested by guidelines is exceeded manifold in India (300 minutes versus 140-170 minutes) compared to the developed world. The reasons for reaching the hospital late can be attributed to socioeconomic status, lack of awareness about the symptoms, presence of different types of health care providers who prevent immediate access to tertiary care centres, lack of ambulance services, traffic congestion, long distances and consultations with family physicians.

Depending on the local circumstances, either immediate thrombolysis or rapid transfer to an experienced tertiary care centre is preferred. Pharmacoinvasive recanalisation is particularly attractive in Indian context and may ultimately benefit the patients.

When treating patients with STEMI, the time from onset of symptoms to reperfusion is crucial for salvaging myocardium. Recent data clearly demonstrates that time to reperfusion is positively associated with infarct size, edema, and micro vascular obstruction, and inversely associated with the degree of myocardial salvage, as determined by cardiac magnetic resonance imaging of STEMI patients after successful PCI. Indeed, the amount of myocardium salvaged drops markedly when the reperfusion time exceeds 90 minutes2.

This prospective, observational study aims at assessing the efficacy and safety of a strategy of early fibrinolytic treatment with Reteplase (rPA) and additional antiplatelet and antithrombin therapy followed by catheterization within 3-24 hours or Rescue Coronary Intervention in patients with STEMI within 12 hours of onset of symptoms.

Primary PCI in Acute Myocardial Infarction is a preferred mode of revascularization as compared to thrombolytic therapy.  There is no primary data on rPA facilitated PCI. In Indian context TNK or rPA facilitated PCI (Pharmacoinvasive therapy) is a more practical solution.  This study aims to confirm the efficacy and safety of Pharmacoinvasive therapy in 200 patients with rPA.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-15
• Last Update Posted: 2017-07-04

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 200

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 V2–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.

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.

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.	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 events	1.Death, Reinfarction, repeat revascularization

Trial Locations

Locations (3)

Christian Fellowship Hospital; 🇮🇳 Dindigul, TAMIL NADU, India

Kovai Medical Center and Hospital; 🇮🇳 Coimbatore, TAMIL NADU, India

Pollachi Cardiac Center; 🇮🇳 Coimbatore, TAMIL NADU, India

Christian Fellowship Hospital

🇮🇳Dindigul, TAMIL NADU, India

Vimal Abraham

Principal investigator

9597301704

Vimalabraham29@gmail.com