A phase 3 study of low-dose intracoronary thrombolytic therapy in STEMI (heart attack) patients

Phase 3

Completed

• Conditions: ST elevation myocardial infarction; Cardiovascular - Coronary heart disease

• Registration Number: ACTRN12618000778280
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-09
• Study Completion: 2023-09-05
• Last Update Posted: 9 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1) Adult men and women aged over 18 who present with STEMI within 12 hours of symptom onset. Patients will be eligible if they have symptoms consistent with myocardial ischaemia (chest pain, dyspnoea) for at least 20 minutes accompanied by definite ECGs indicating STEMI as defined by Australian NHF guidelines;

2) Willing and able to comply with all study requirements, including treatment, assessment and clinic visit attendances;

3) Able to personally read and understand the Participant Information and Consent Form and provide written, signed and dated informed consent to participate in the study.

4) (At time of PCI) Patient has received metallic drug-eluting stent

Exclusion Criteria

At the time of screening or prior to randomisation, no known:
1) Previous coronary bypass grafting
2) Patients with other residual lesions with >50% diameter stenosis in the culprit vessel
3) Patients with prior myocardial infarction in the target territory
4) Presence of contraindications to thrombolytic therapy (including history of stroke and recent brain surgery active internal bleeding; history of cerebrovascular accident; intracranial or intraspinal surgery, or trauma within 2 months; intracranial neoplasm, arteriovenous malformation, or aneurysm; known bleeding diathesis; and severe uncontrolled hypertension)
5) Presence of contraindications to adenosine infusion for IMR measurement including sinus node disease, moderate to severe bronchoconstrictive disease and second or third-degree AV block
6) Concurrent illness, including severe infection that may jeopardise the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety
7) Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol
8) Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal, infertile, or use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration. Men must have been surgically sterilised or use a (double if required) barrier method of contraception.
9) (Imaging (CMR) substudy only) Presence of contraindications to contrast enhanced MRI including pacemakers, metallic prostheses and estimated glomerular filtration rate of <30mL/min.
10) (At time of PCI) Patients who do not undergo primary PCI due to lack of severity of culprit lesion or other reasons.

Study & Design

• Study Type: Interventional
• Study Design: Not specified