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


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Trial ID: NCT03998319


Heart attacks are caused by a blood clot blocking the blood vessels of the heart, preventing blood getting to the heart muscle. Opening up the artery with a balloon (angioplasty) and a small mesh tube (stent) although life saving can cause this clot to break up and get washed downstream, which can make the heart attack worse. The investigators can measure the amount of damage caused to the microcirculation by calculating the IMR (Index of Microcirculatory resistance). This can be measured by a wire in the coronary artery with a pressure sensor at the tip. If the IMR is elevated, it is suggestive of extensive microcirculatory damage. A clot dissolving medicine can be administered in the artery to try and reduce the IMR which can reduce damage to the heart muscle and improve outcomes. Impaired microcirculatory perfusion in patients as a result of ST-elevation myocardial infarction (STEMI) is associated with poor clinical outcomes. This project seeks to identify patients with impaired microcirculatory perfusion after STEMI and to assess whether acute improvement in microcirculatory perfusion in these patients by the use of intracoronary thrombolytic therapy results in improved clinical outcomes.

Official Title

A Randomised Trial to Evaluate the Efficacy of Low-dose Intracoronary Tenecteplase in ST-Elevation Myocardial Infarction (STEMI) Patients With High Microvascular Resistance Post-percutaneous Coronary Intervention (PCI).

Stanford Investigator(s)

William Fearon, MD
William Fearon, MD

Professor of Medicine (Cardiovascular Medicine)


Inclusion Criteria:

   1. Adult men and women aged over 18 who present with STEMI within 6 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 National Heart Foundation (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

   5. Participant consents to have a 3-7 day (discharge) and 5 month follow up cardiac MRI

Exclusion Criteria:

At the time of screening and/or prior to randomisation, no known;

   1. Previous coronary bypass grafting

   2. Other residual lesions with ≥50% diameter stenosis in the culprit vessel

   3. 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 atrioventricular (AV) block

   6. Diagnosis of metastatic disease

   7. Concurrent illness, including severe infection that may jeopardise the ability of the
   patient to undergo the procedures outlined in this protocol with reasonable safety

   8. Serious medical or psychiatric conditions that might limit the ability of the patient
   to comply with the protocol

   9. 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

10. Participation in any investigational study in the previous 30 days

   Other exclusion criteria:

11. (Cardiac MRI cohort only) Presence of contraindications to contrast enhanced MRI
   including severe claustrophobia, pregnancy, pacemakers, non-MRI compatible aneurysm
   clips, defibrillators and estimated glomerular filtration rate of <30mL/min.

   (At time of PCI)

12. Patients who received GpIIb/IIIa treatment prior to IMR measurement

13. Patients who do not undergo primary PCI due to lack of severity of culprit lesion or
   other reasons.


drug: Tenecteplase (1/3 systemic weight based dose)

other: Sterile water for injection (WFI)


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
William Fearon, MD