A Phase 4 interventional study of Ticagrelor 60 mg and Prasugrel 5mg in Myocardial Infarction, Diabetes Mellitus and Coronary Artery Disease, sponsored by Attikon Hospital. Completed at 1 site in Greece. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-03-05.
Sponsored by Attikon Hospital · Phase 4, Interventional, and Treatment
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Among 36 studies testing ticagrelor in Myocardial Infarction — 3 open to participants now, 3 under way, 1 of them phase 3. Ticagrelor · Myocardial Infarction.
Among the 36 studies testing ticagrelor in Myocardial Infarction, this one is the 34th largest by enrollment, is one of 3 that started in 2018, is one of 20 in phase 4, and was the 23rd registered.
2,270 studies on the registry are indexed under Myocardial Infarction; 371 are open to participants now.
Browse Myocardial Infarction studies →3 of the 36 studies testing ticagrelor in Myocardial Infarction are open now, in 7 countries. Recruiting first, the newest first:
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz · Sites in Ireland, Latvia, Norway and 2 more countries
Ages 18+
Assistance Publique - Hôpitaux de Paris · Sites in France
Ages 18+
Nova Scotia Health Authority · Sites in Canada
Ages 55+
By country, each count listing its studies:
Ticagrelor: first FDA approval 2011 (BRILINTA), first EMA approval 2010. What it is approved for, and how studies give it, is on its page →
Of the 255 Myocardial Infarction studies recruiting now, 172 (67%) set no upper age limit and 26 (10%) stop at 75 or younger; 16 take children under 18; 27 take healthy volunteers.
This study: 50 Years to 90 Years · all sexes · no healthy volunteers.
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36 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 3 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 20 is below the median of 150 across 1,314 interventional studies indexed under Myocardial Infarction.
Median enrollment 132 across the 36 interventional studies. Of the 26 that completed or were terminated, 12 (46%) have results posted.
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7 of 36 have an industry lead sponsor. The 10 most frequent:
Attikon Hospital is the lead sponsor of 86 studies on the registry; 17 are open to participants now.
Attikon Hospital has 1 study filed under Myocardial Infarction — fewer than ten, so there is no comparison to draw.
1 of the studies testing ticagrelor in Myocardial Infarction that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05476991Phase 3Assistance Publique - Hôpitaux de ParisEvaluation of Low Dose Colchicine and Ticagrelor in Prevention of Ischemic Stroke in Patients With Stroke Due to Atherosclerosis | 2027-09-01 |
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Among the 36 studies testing ticagrelor in Myocardial Infarction, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Taken together the results from DAPT and PEGASUS-TIMI54, it appears that physicians may consider extending beyond 1 year or reinitiating treatment with a thienopyridine or ticagrelor 60mg bid in patients with a prior MI and features of high ischemic and low bleeding risk. Comparative clinical or pharmacodynamic studies, however, between prasugrel 5 mg od and ticagrelor 60 mg bid in the chronic phase of stable post MI patients have not been performed.
In light of this, we believe that a dedicated pharmacodynamic study of ticagrelor 60 bid mg vs prasugrel 5 mg od in a PEGASUS-like population would be informative for the practicing clinician, thus setting the rationale for conducting this specifically designed investigation.
This is a prospective, randomized, single blind, single center, crossover study. Eligible patients undergoing P2Y12 receptor antagonist therapy before screening will undergo a 14-day minimum washout period before randomization. Following screening/washout period (visit 1), patients will be randomized (visit 2, time 0) in 1:1 fashion to either prasugrel 5 mg od or ticagrelor 60 mg bid. Following 14±2 days (visit 3) patients will receive alternate treatment for additional 14 days (visit 4). Platelet reactivity assessment will be performed with the VerifyNow P2Y12 reaction assay at time 0, prior to first study drug dose. At visit 3 platelet function will be assessed at 2-4 hours post dose and prior to crossover. At visit 4 also platelet function will be assessed at 2-4 hours post study drug post dose. All patients will receive concomitant aspirin (100 mg/d) and standard secondary prevention medication.
The primary endpoint is the platelet reactivity measured in P2Y12 reaction units (PRU) at the end of the 2 study periods (pre-crossover and post-crossover).
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.
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.
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.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
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.
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.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
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.
Ticagrelor 60mg twice daily followed by Prasugrel 5mg once daily
Drug: Ticagrelor 60 mg · Drug: Prasugrel 5mg
Prasugrel 5m once daily followed by Ticagrelor 60mg twice daily
Drug: Ticagrelor 60 mg · Drug: Prasugrel 5mg
Ticagrelor 60 mg twice daily
Prasugrel 5 mg once daily
Platelet reactivity measured in P2Y12 reaction units (PRU) at the end of the 2 study periods
Platelet reactivity measured in P2Y12 reaction units (PRU) at the end of the 2 study periods (pre-crossover and post-crossover).
Time frame: 14 days
High platelet reactivity rate at the end of the 2 study periods
High platelet reactivity rate (defined as \>208 PRU) at the end of the 2 study periods
Time frame: 14 days
VerifyNow P2Y12 assay % inhibition, using the TRAP-induced response at the end of the 2 study periods
VerifyNow P2Y12 assay % inhibition, using the TRAP-induced (BASE channel) response at the end of the 2 study periods
Time frame: 14 days
Plan to share: Undecided
Ran from Jan 2018 to primary completion in Jan 2019, 12 months.
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 12 months is below 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 Mar 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Ticagrelor · Prasugrel
Attikon Hospital