A Phase 4 interventional study of Prasugrel and Ticagrelor in Coronary Artery Disease, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-09-16.
Sponsored by University of Florida · Phase 4, Interventional, and Treatment
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Among 40 studies testing prasugrel in Coronary Artery Disease — 4 open to participants now, 4 under way, 1 of them phase 3. prasugrel · Coronary Artery Disease.
Among the 40 studies testing prasugrel in Coronary Artery Disease, this one is the 40th largest by enrollment, is one of 2 that started in 2018, is one of 23 in phase 4, and was the 33rd registered.
4,861 studies on the registry are indexed under Coronary Artery Disease; 892 are open to participants now.
Browse Coronary Artery Disease studies →4 of the 40 studies testing prasugrel in Coronary Artery Disease are open now, in 2 countries. Recruiting first, the newest first:
Cardiocentro Ticino · Sites in Switzerland
Ages 18+
University of Florida · Sites in United States
Ages 18+
University of Florida · Sites in United States
Ages 18+
University of Florida · Sites in United States
Ages 18–75
By country, each count listing its studies:
prasugrel: first FDA approval 2009 (EFFIENT), first EMA approval 2009. What it is approved for, and how studies give it, is on its page →
Of the 588 Coronary Artery Disease studies recruiting now, 403 (69%) set no upper age limit and 68 (12%) stop at 75 or younger; 38 take children under 18; 47 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
40 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 14 is below the median of 124 across 3,009 interventional studies indexed under Coronary Artery Disease.
Median enrollment 84 across the 40 interventional studies. Of the 30 that completed or were terminated, 18 (60%) have results posted.
This tab as a report to print or save as PDF → With an account.
11 of 40 have an industry lead sponsor. The 10 most frequent:
University of Florida is the lead sponsor of 1,288 studies on the registry; 200 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 143 (79%) have results posted.
40 studies in Coronary Artery Disease by University of Florida: 6 open now, 8 under way, none of them phase 3. Of 32 finished, 24 (75%) have results posted.
Among the 40 studies in Coronary Artery Disease by University of Florida, this one is the 33rd largest by enrollment of the 35 interventional ones that give a count, is one of 3 that started in 2018, is one of 26 in phase 4, and was the 22nd registered.
University of Florida’s Coronary Artery Disease studies by the year they started, since 1997.
1 of the studies testing prasugrel in Coronary Artery Disease that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07025148University of FloridaDual Antiplatelet Therapy Escalation From Standard-dose Clopidogrel to Low-Dose Prasugrel in Patients With High Bleeding and Ischemic Risk Undergoing PCI: A Prospective, Randomized Pharmacodynamic Study (TAILOR-BLEED-2) | 2027-08-01 |
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Among the 40 studies testing prasugrel in Coronary Artery Disease, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among University of Florida’s 40 in Coronary Artery Disease:
This tab as a report to print or save as PDF → With an account.
Polymorphisms of the cytochrome P450 (CYP) 2C19 enzyme has been consistently shown to modulate clopidogrel response. Accordingly, the Food and Drug Administration (FDA) has issued a warning on the potential for reduced efficacy of clopidogrel among carriers of loss-of-function alleles (LOF) for CYP2C19 and suggest considering alternative antiplatelet therapies for these individuals.
The pharmacodynamic (PD) effects of prasugrel and ticagrelor are not affected by CYP2C19 genetic polymorphisms. However, to date there are no head-to-head PD comparisons between these agents among patients with different CYP2C19 genetic polymorphisms, which is currently under investigation in CAD patients undergoing PCI at UF Health-Jacksonville (UFJ 2014-12, NCT 02065479). In order to rule out play of chance findings, pharmacogenetic investigations require external validation cohorts to support the study findings. Therefore, the present randomized study is designed to serve as an external validation cohort conducted in patients with established CAD not undergoing PCI testing the non-inferiority in platelet reactivity of prasugrel versus ticagrelor among CYP2C19 LOF allele carriers.
Therapeutic inhibition of platelet activation is essential for the management of ischemic cardiovascular disease. The use of platelet adenosine diphosphate (ADP) P2Y12 receptor antagonists (clopidogrel, prasugrel, and ticagrelor) in addition to aspirin are associated with a decrease in cardiovascular events in high-risk coronary artery disease (CAD) patients. Clopidogrel is the most broadly utilized P2Y12 receptor antagonist. However, among clopidogrel treated patients, there is broad variability in antiplatelet drug response which is known carry prognostic implications. Polymorphisms of the cytochrome P450 (CYP) 2C19 enzyme has been consistently shown to modulate clopidogrel response. Accordingly, the Food and Drug Administration (FDA) has issued a warning on the potential for reduced efficacy of clopidogrel among carriers of loss-of-function alleles (LOF) for CYP2C19 and suggest considering alternative antiplatelet therapies for these individuals.
The pharmacodynamic (PD) effects of prasugrel and ticagrelor are not affected by CYP2C19 genetic polymorphisms. However, to date there are no head-to-head PD comparisons between these agents among patients with different CYP2C19 genetic polymorphisms which is currently under investigation in CAD patients undergoing PCI at UF Health-Jacksonville (UFJ 2014-12, NCT 02065479). In order to rule out play of chance findings, pharmacogenetic investigations require external validation cohorts to support the study findings. Therefore, the present randomized study is designed to serve as an external validation cohort conducted in patients with established CAD not undergoing PCI testing the non-inferiority in platelet reactivity of prasugrel versus ticagrelor among CYP2C19 LOF allele carriers.
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.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
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.
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.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
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.
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.
Patients will be randomly (1:1) assigned to receive FDA approved doses of either prasugrel (60 mg loading dose - 10 mg/day maintenance dose) or ticagrelor (180 mg loading dose - 90 mg b.i.d maintenance dose).
Drug: Prasugrel
Patients will be randomly (1:1) assigned to receive FDA approved doses of either prasugrel (60 mg loading dose - 10 mg/day maintenance dose) or ticagrelor (180 mg loading dose - 90 mg b.i.d maintenance dose).
Drug: Ticagrelor
Maintenance dose will be maintained for 10±3 days.
Also known as: Effient
Maintenance dose will be maintained for 10±3 days.
Also known as: Brilinta
P2Y12 Reaction Unit (PRU)
Platelet reactivity measured by VerifyNow and reported as PRU
Time frame: at 24 hours post loading dose
| Milestone | Prasugrel | Ticagrelor |
|---|---|---|
| Started | 7 | 7 |
| Completed | 7 | 6 |
| Not completed | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
Platelet reactivity measured by VerifyNow and reported as PRU
| PRU | Prasugrel | Ticagrelor |
|---|---|---|
| P2Y12 Reaction Unit (PRU) | 5 ± 10 | 24 ± 22 |
Collected over 10 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Prasugrel | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Ticagrelor | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Age, Continuous(years) | Prasugrel | Ticagrelor | Total |
|---|---|---|---|
| Mean | 58 ± 8 | 60 ± 8 | 59 ± 8 |
| Sex: Female, Male(Participants) | Prasugrel | Ticagrelor | Total |
|---|---|---|---|
| Female | 2 | 2 | 4 |
| Male | 5 | 5 | 10 |
| Race (NIH/OMB)(Participants) | Prasugrel | Ticagrelor | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 4 | 7 |
| White | 4 | 3 | 7 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| diabetes mellitus(Participants) | Prasugrel | Ticagrelor | Total |
|---|---|---|---|
| Count of participants | 4 | 2 | 6 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from May 2018 to primary completion in Mar 2019, 9 months.
Results were first posted in Aug 2020, 1 year 5 months after primary completion.
Of 180 non-industry phase 4 interventional studies under Coronary Artery Disease, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 59. This study's 9 months is below that.
Counting every sponsor, half of 193 studies reached it within 35 months; a quarter within 19 and three quarters within 58.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Prasugrel · Ticagrelor