A Phase 4 interventional study of Tenecteplase and Clopidogrel in Myocardial Infarction, sponsored by KU Leuven. Completed at 50 sites in 10 countries. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2024-10-04.
Sponsored by KU Leuven · Phase 4, Interventional, and Treatment
In patients ≥ 60yrs with acute ST-elevation myocardial infarction randomised within 3 hours of onset of symptoms the efficacy and safety of a strategy of early fibrinolytic treatment with half-dose tenecteplase and additional antiplatelet therapy with a loading dose of 300 mg clopidogrel, aspirin and coupled with antithrombin therapy followed by catheterisation within 6-24 hours or rescue coronary intervention as required, will be compared to a strategy of primary PCI with a P2Y12 antagonist and antithrombin treatment according to local standards.
2,270 studies on the registry are indexed under Myocardial Infarction; 371 are open to participants now.
This study's enrollment of 609 is above the median of 150 across 1,314 interventional studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →KU Leuven is the lead sponsor of 373 studies on the registry; 65 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
12-lead indicative of an acute STEMI (ST-elevation will be measured from the J point; scale: 1 mm per 0.1 mV):
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Half-dose tenecteplase and additional antiplatelet therapy with a loading dose of 300 mg clopidogrel, aspirin and coupled with antithrombin therapy followed by coronary angiography within 6-24 hours or rescue coronary intervention as required.
Drug: Tenecteplase · Drug: Clopidogrel · Procedure: Coronary angiography
Primary PCI with a P2Y12 antagonist and antithrombin treatment according to local standards.
Procedure: Primary PCI
Half dose Tenecteplase
Also known as: TNKase, Metalyse
300 mg p.o. initial loading dose. Maintenance dose of 75 mg p.o. once daily. The maintenance dose of Clopidogrel (75 mg p.o. per day) should be continued for 1 year.
Coronary angiography followed by PCI or CABG if required, rescue PCI if required
Primary PCI accoring to local standards
Successful Reperfusion
Worst-lead ST-segment elevation resolution ≥ 50% 30 min post angiogram/PCI
Time frame: 30 min post angiogram/PCI
Composite Clinical Efficacy End Point: All Cause Death, Shock, CHF and Reinfarction at 30 Days
Time frame: 30 days
Total Stroke
Number of patients with stroke (intracranial haemorrhage, ischaemic, haemorrhagic conversion)
Time frame: 30 days
Major Non-intrancranial Bleedings
Time frame: 30 days
| Milestone | Pharmaco-invasive Strategy | Standard Primary PCI |
|---|---|---|
| Started | 405 | 204 |
| Completed | 401 | 203 |
| Not completed | 4 | 1 |
Worst-lead ST-segment elevation resolution ≥ 50% 30 min post angiogram/PCI
| Participants | Pharmaco-invasive Strategy | Standard Primary PCI |
|---|---|---|
| Successful Reperfusion | 305 | 149 |
| Participants | Pharmaco-invasive Strategy | Standard Primary PCI |
|---|---|---|
| Composite Clinical Efficacy End Point: All Cause Death, Shock, CHF and Reinfarction at 30 Days | 51 | 27 |
Number of patients with stroke (intracranial haemorrhage, ischaemic, haemorrhagic conversion)
| Participants | Pharmaco-invasive Strategy | Standard Primary PCI |
|---|---|---|
| Total Stroke | 9 | 1 |
| Participants | Pharmaco-invasive Strategy | Standard Primary PCI |
|---|---|---|
| Major Non-intrancranial Bleedings | 5 | 2 |
Collected over 30 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pharmaco-invasive Strategy | 37/401 (9.2%) | 69/401 (17.2%) | 0/401 (0%) |
| Standard Primary PCI | 18/203 (8.9%) | 32/203 (15.8%) | 0/203 (0%) |
| Event | Pharmaco-invasive Strategy | Standard Primary PCI |
|---|---|---|
| cardiogenic shockCardiac disorders | 18/400 | 11/203 |
| heart failureCardiac disorders | 14/400 | 9/203 |
| reinfarctionCardiac disorders | 10/400 | 5/203 |
| myocardial ruptureCardiac disorders | 7/401 | 1/203 |
| intracranial hemorrhageNervous system disorders | 6/400 | 0/203 |
| major nonintracranial bleedingVascular disorders | 5/400 | 2/203 |
| ventricular tachycardiaCardiac disorders | 4/401 | 0/203 |
| ventricular fibrillationCardiac disorders | 4/401 | 0/203 |
| PneumoniaInfections and infestations | 4/401 | 2/203 |
| coronary arterial dissectionCardiac disorders | 0/401 | 2/203 |
| Age, Categorical(Participants) | Pharmaco-invasive Strategy | Standard Primary PCI | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 113 | 47 | 160 |
| >=65 years | 288 | 156 | 444 |
| Age, Continuous(years) | Pharmaco-invasive Strategy | Standard Primary PCI | Total |
|---|---|---|---|
| Mean | 70 ± 8 | 71 ± 8 | 70 ± 8 |
| Sex: Female, Male(Participants) | Pharmaco-invasive Strategy | Standard Primary PCI | Total |
|---|---|---|---|
| Female | 131 | 66 | 197 |
| Male | 270 | 137 | 407 |
| Race and Ethnicity Not Collected(Participants) | Pharmaco-invasive Strategy | Standard Primary PCI | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Pharmaco-invasive Strategy | Standard Primary PCI | Total |
|---|---|---|---|
| Canada | 66 | 34 | 100 |
| Brazil | 14 | 6 | 20 |
| Mexico | 53 | 28 | 81 |
| Australia | 6 | 3 | 9 |
| Chile | 10 | 5 | 15 |
| France | 28 | 14 | 42 |
| Serbia | 117 | 60 | 177 |
| Montenegro | 5 | 3 | 8 |
| Russia | 95 | 47 | 142 |
| Spain | 7 | 3 | 10 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Aug 2017 to primary completion in Oct 2022, 62 months.
Results were first posted in Oct 2024, 1 year 11 months after primary completion.
Of 83 non-industry phase 4 interventional studies under Myocardial Infarction, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 78. This study's 62 months is above that.
Counting every sponsor, half of 87 studies reached it within 42 months; a quarter within 22 and three quarters within 78.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Tenecteplase · Clopidogrel