Platelet inhibition with Ticagrelor 60 mg versus Ticagrelor 90 mg twice daily in elderly patients with acute coronary syndrome (ACS).

Platelet inhibition with Ticagrelor 60 mg versus Ticagrelor 90 mg twice daily in elderly patients with acute coronary syndrome (ACS). - Platelet inhibition with Ticagrelor 60 mg versus Ticagrelor 90 mg twice daily in elderly patients wi

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-002391-13-IT

Enrollment

Registered

2020-10-07

Start date

2021-01-08

Completion date

Unknown

Last updated

2025-02-17

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

Conditions

Acute coronary syndrome MedDRA version: 20.0 Level: PT Classification code 10051592 Term: Acute coronary syndrome System Organ Class: 10007541 - Cardiac disorders

Interventions

Trade Name: BRILIQUE 90 MG COMPRESSE RIVESTITE CON FILM Product Name: TICAGRELOR 90 mg Product Code: [TICAGRELOR 90 mg] Pharmaceutical Form: Film-coated tablet INN or Proposed INN: TICAGRELOR CAS Numb

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Ability to provide written informed consent in a time window 1 to 3 days after successful PCI; 2. Male or female, age = 75 years at screening; ¿ 3. ACS at the time of the index hospitalization; 4. Use of a loading dose of 180 mg of ticagrelor administered after diagnosis of ACS or after PCI; 5. Use of a maintenance dose of 90 mg twice daily of ticagrelor of at least 48 hours after the loading dose; 6. Successful PCI (Thrombolysis In Myocardial Infarction [TIMI] flow 3 and residual coronary stenosis =65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

Exclusion criteria: 1. Use of glycoprotein IIb/IIIa receptor inhibitors; 2. Need for chronic oral anticoagulant therapy; 3. Prior fibrinolysis; 4. Unstable clinical status (hemodynamic or electrical instability); 5. Planned surgery requiring DAPT discontinuation during the study; 6. Prior stroke, transient ischemic attack or intracranial bleeding; 7. Active bleeding; 8. Severe anemia (hemoglobin < 8g/dL); 9. Platelet count =80x103/ml; 10. Renal failure (hemodialysis or creatinine clearance = 30 ml/min calculated with Cockroft- Gault formula); 11. Severe hepatic dysfunction (baseline alanine aminotransferase = 2.5 times the upper limit of normal); 12. Known hypersensitivity or contraindication to ticagrelor; 13. Inhability to sign informed consent; 14. Under judicial protection, tutorship or curatorship; 15. Unable to understand and follow study-related instructions; 16. Enrollment in another investigational device or drug study.

Design outcomes

Primary

Measure	Time frame
Main Objective: The main aim of the trial is to determine whether the efficacy of ticagrelor 60 mg twice daily is not inferior to that of ticagrelor 90 mg twice daily among elderly patients with ACS undergoing PCI.;Secondary Objective: To evaluate adverse events in patients treated with ticagrelor 60 mg and ticagrelor 90 mg. To determine the pharmacokinetic profile of ticagrelor 60 mg twice daily versus ticagrelor 90 mg twice daily.;Primary end point(s): The primary endpoint of the trial will be the comparison of pre-dose P2Y12 reaction units (PRU) determined by VerifyNow- P2Y12 assay (Accumetrics, San Diego, California) at 14 days after treatment with ticagrelor 60 mg or 90 mg.;Timepoint(s) of evaluation of this end point: at baseline and 14 and 28 days after treatment with ticagrelor 60 mg or 90 mg.	—

Measure

Time frame

Main Objective: The main aim of the trial is to determine whether the efficacy of ticagrelor 60 mg twice daily is not inferior to that of ticagrelor 90 mg twice daily among elderly patients with ACS undergoing PCI.;Secondary Objective: To evaluate adverse events in patients treated with ticagrelor 60 mg and ticagrelor 90 mg. To determine the pharmacokinetic profile of ticagrelor 60 mg twice daily versus ticagrelor 90 mg twice daily.;Primary end point(s): The primary endpoint of the trial will be the comparison of pre-dose P2Y12 reaction units (PRU) determined by VerifyNow- P2Y12 assay (Accumetrics, San Diego, California) at 14 days after treatment with ticagrelor 60 mg or 90 mg.;Timepoint(s) of evaluation of this end point: at baseline and 14 and 28 days after treatment with ticagrelor 60 mg or 90 mg.

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Secondary

Measure	Time frame
Secondary end point(s): High platelet reactivity (HPR) and ADP-induced platelet reactivity measured through light transmittance aggregometry (LTA) and Multiplate Analyzer.; Non ADP-induced platelet reactivity in patients treated with ticagrelor 60 mg or ticagrelor 90 mg, measured through Multiplate Analyzer (arachidonic acid-, collagen-, and thrombin receptor-activating test).; Frequency of any revascularization; Frequency of Unstable angina; Frequency of Bleeding events according to the BARC, TIMI and GUSTO classification.; Plasma levels of ticagrelor and its active metabolite AR-C124910XX.; Frequency of Spontaneous myocardial infarction;; The composite of all-cause death, myocardial infarction, or stroke; The composite of cardiovascular death, myocardial infarction, urgent target-lesion revascularization;;Timepoint(s) of evaluation of this end point: 3 time points: 1) Time 1: at baseline before randomization; 2) Time 2: 14 days after the first randomly assigned treatment, including 2 samples, before and 2 hours after the last dose of the initial assigned treatment; 3) Time: 14 days after the second randomly assigned treatment, including 2 samples, before and 2 hours after the last dose of the second assigned treatment; 3 time points: 1) Time 1: at baseline before randomization; 2) Time 2: 14 days after the first randomly assigned treatment, including 2 samples, before and 2 hours after the last dose of the initial assigned treatment; 3) Time: 14 days after the second randomly assigned treatment, including 2 samples, before and 2 hours af	—

Measure

Time frame

Secondary end point(s): High platelet reactivity (HPR) and ADP-induced platelet reactivity measured through light transmittance aggregometry (LTA) and Multiplate Analyzer.; Non ADP-induced platelet reactivity in patients treated with ticagrelor 60 mg or ticagrelor 90 mg, measured through Multiplate Analyzer (arachidonic acid-, collagen-, and thrombin receptor-activating test).; Frequency of any revascularization; Frequency of Unstable angina; Frequency of Bleeding events according to the BARC, TIMI and GUSTO classification.; Plasma levels of ticagrelor and its active metabolite AR-C124910XX.; Frequency of Spontaneous myocardial infarction;; The composite of all-cause death, myocardial infarction, or stroke; The composite of cardiovascular death, myocardial infarction, urgent target-lesion revascularization;;Timepoint(s) of evaluation of this end point: 3 time points: 1) Time 1: at baseline before randomization; 2) Time 2: 14 days after the first randomly assigned treatment, including 2 samples, before and 2 hours after the last dose of the initial assigned treatment; 3) Time: 14 days after the second randomly assigned treatment, including 2 samples, before and 2 hours after the last dose of the second assigned treatment; 3 time points: 1) Time 1: at baseline before randomization; 2) Time 2: 14 days after the first randomly assigned treatment, including 2 samples, before and 2 hours after the last dose of the initial assigned treatment; 3) Time: 14 days after the second randomly assigned treatment, including 2 samples, before and 2 hours af

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Countries

Italy

Contacts

Public ContactCRO

CD Pharma Group S.r.l.

chiara.olgiati@cdpharma.it0289051088

Outcome results

None listed

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