A comparative study of platelet inhibition between the lower ticagrelor and prasugrel doses in patients with prior myocardial infarction

A randomized, pharmacodynamic comparison of ticagrelor 60mg bid vs prasugrel 5mg in patients with prior myocardial infarction

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004959-80-GR

Enrollment

Registered

2017-06-14

Start date

2017-08-01

Completion date

Unknown

Last updated

2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

In this study we aim to compare the platelet inhibition of 60mg ticagrelor bid versus 5mg prasugrel in patients with prior myocardial infarction within previous 1-3 years

Interventions

Trade Name: Brlique Product Name: Ticagrelor Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ticagrelor Other descriptive name: TICAGRELOR Concentration unit: mg milligram(s) Concentratio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Provision of informed consent prior to any study specific procedures 2. Post- menopausal female 3. A spontaneous myocardial infarction 1 to 3 years before enrollment and at least 50 years of age. In addition, at least one of the following high-risk features: age of 65 years or older, diabetes mellitus requiring medication, a second prior spontaneous MI, multivessel coronary artery disease, or chronic renal dysfunction, (estimated creatinine clearance of =65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: 1. Planned use of a P2Y12 receptor antagonist, dipyridamole, cilostazol, or anticoagulant therapy during the study period 2. Known allergy to ticagrelor or prasugrel or any excipients 3. A bleeding disorder or a history of an ischemic stroke or intracranial bleeding, a central nervous system tumor, or an intracranial vascular abnormality 4. Gastrointestinal bleeding within the previous 6 months or major surgery within the previous 30 days

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is pharmacodynamic comparison between 60mg ticagrelor bid and 5mg prasugrel in post-myocardial infarction patients;Secondary Objective: VerifyNow P2Y12 assay % inhibition, using the TRAP-induced (BASE channel) response and High platelet reactivity rate (PRU >208) during the pre-crossover and post-crossover periods. Bleeding (BARC classification) and major adverse cardiovascular events (cardiovascular death, myocardial infarction, and stroke) will be evaluated during the same periods ;Primary end point(s): The primary endpoint of the study will be platelet reactivity in terms of P2Y12 platelet reactivity units (PRU) at the end of the 2 study periods( pre-crossover and post-crossover).;Timepoint(s) of evaluation of this end point: Visit 2,3 and 4	—

Measure

Time frame

Main Objective: The primary objective of this study is pharmacodynamic comparison between 60mg ticagrelor bid and 5mg prasugrel in post-myocardial infarction patients;Secondary Objective: VerifyNow P2Y12 assay % inhibition, using the TRAP-induced (BASE channel) response and High platelet reactivity rate (PRU >208) during the pre-crossover and post-crossover periods. Bleeding (BARC classification) and major adverse cardiovascular events (cardiovascular death, myocardial infarction, and stroke) will be evaluated during the same periods ;Primary end point(s): The primary endpoint of the study will be platelet reactivity in terms of P2Y12 platelet reactivity units (PRU) at the end of the 2 study periods( pre-crossover and post-crossover).;Timepoint(s) of evaluation of this end point: Visit 2,3 and 4

—

Secondary

Measure	Time frame
Secondary end point(s): VerifyNow P2Y12 assay % inhibition, using the TRAP-induced (BASE channel) response and High platelet reactivity rate (PRU >208) during the pre-crossover and post-crossover periods. Bleeding (BARC classification) and major adverse cardiovascular events (cardiovascular death, myocardial infarction, and stroke) will be evaluated during the same periods ;Timepoint(s) of evaluation of this end point: Between Visit 2 of the first patient enrolled till the end of the trial(32 days after Visit 2 of the last patient enrolled in the study)	—

Measure

Time frame

Secondary end point(s): VerifyNow P2Y12 assay % inhibition, using the TRAP-induced (BASE channel) response and High platelet reactivity rate (PRU >208) during the pre-crossover and post-crossover periods. Bleeding (BARC classification) and major adverse cardiovascular events (cardiovascular death, myocardial infarction, and stroke) will be evaluated during the same periods ;Timepoint(s) of evaluation of this end point: Between Visit 2 of the first patient enrolled till the end of the trial(32 days after Visit 2 of the last patient enrolled in the study)

—

Countries

Greece

Contacts

Public ContactSpecial Account For Research Funds

Special Account For Research Funds- National and Capodistrian University of Athens

rc@elke.uoa.gr00302103889194

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026