What is tenecteplase studying for heart attack patients?

Tenecteplase is being studied to see if a low dose given directly into the heart artery can reduce damage caused by blocked blood flow after a heart attack. The trial evaluates if this treatment improves heart muscle recovery and reduces complications. It is sponsored by the University of Sydney and focuses on patients with STEMI and high microvascular resistance.

Who may be eligible for this heart attack clinical trial?

Adults 18 years or older who have had a STEMI heart attack within 6 hours and received a specific stent in their artery may be eligible. Both men and women can join, but people with certain medical conditions like prior bypass surgery or recent stroke are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this heart attack clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or accommodation costs.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID03998319

Low-dose Intracoronary Tenecteplase to Improve Blood Flow After Heart Attack in STEMI Patients With High Microvascular Resistance A Phase 3 Randomized Study Following PCI Treatment

Led by University of Sydney · Updated on 2024-09-27

445

Participants Needed

Research Sites

104 weeks

Total Duration

AI-Summary

What this Trial Is About

Heart attacks occur when a blood clot blocks the hearts blood vessels, stopping blood flow to the heart muscle. This trial focuses on patients with ST-elevation myocardial infarction STEMI and looks at how microcirculatory damage can be measured using the Index of Microcirculatory Resistance IMR. The study aims to find out if treating patients with impaired microcirculatory perfusion using low-dose intracoronary thrombolytic therapy can reduce heart muscle damage and improve clinical outcomes. Participants who have had a heart attack and undergone angioplasty will have their IMR measured. Those with an IMR above 32 will be randomly assigned to receive either low-dose tenecteplase a clot-dissolving drug or a placebo sterile water administered directly into the coronary artery. Patients with lower IMR will be followed in a registry. The treatment is given as an intracoronary infusion over 3 minutes. Cardiac enzymes, MRI scans, and other heart function tests will be done at various time points. During the study, participants will have heart enzyme tests at hospital admission and discharge. Those in the randomised group will receive cardiac MRI scans at discharge and six months later. Follow-up visits will occur at 30 days, then 6, 12, and 24 months after discharge to monitor heart function, rehospitalisation, and mortality. The main outcomes measured include cardiovascular death, heart failure rehospitalisation, heart attack size, and bleeding events, with safety and efficacy monitored closely throughout the study period.

CONDITIONS

Brief Title

A Study of Low-dose Intracoronary Thrombolytic Therapy in STEMI (Heart Attack) Patients.

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Adult men and women aged over 18 who present with STEMI within 6 hours of symptom onset
Symptoms consistent with myocardial ischaemia for at least 20 minutes with ECG indicating STEMI
Willing and able to comply with all study requirements including treatment and clinic visits
Able to read, understand, and provide written informed consent
Received metallic drug-eluting stent at the time of PCI
Consent to have cardiac MRI at 3-7 days (discharge) and 6 months follow-up

You will not qualify if you...

Previous coronary bypass grafting
Other residual lesions with 50% or greater diameter stenosis in the culprit vessel
Prior myocardial infarction in the target territory
Contraindications to thrombolytic therapy such as history of stroke, recent brain surgery, active internal bleeding, cerebrovascular accident, intracranial or spinal surgery or trauma within 2 months, intracranial neoplasm, bleeding disorders, or severe uncontrolled hypertension
Contraindications to adenosine infusion including sinus node disease, moderate to severe bronchoconstrictive disease, second or third-degree AV block
Diagnosis of metastatic disease
Severe concurrent illness or infection that may limit safe participation
Serious medical or psychiatric conditions limiting protocol compliance
Pregnancy, lactation, or inadequate contraception; women of childbearing potential must have negative pregnancy test within 7 days prior to registration; men must use reliable contraception
Participation in any investigational study within the previous 30 days
For cardiac MRI cohort: contraindications to MRI including severe claustrophobia, pacemakers, non-MRI compatible devices, or low kidney function
Patients who received GpIIb/IIIa treatment prior to IMR measurement
Patients who do not undergo primary PCI due to lack of severity of culprit lesion or other reasons

Research Team

Martin Ng, MBBS (Hons)

Rebecca Mister

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Low-dose Intracoronary Tenecteplase to Improve Blood Flow After Heart Attack in STEMI Patients With High Microvascular Resistance A Phase 3 Randomized Study Following PCI Treatment

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria