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

Phase 1

• Conditions: Acute coronary syndrome; MedDRA version: 20.0Level: PTClassification code 10051592Term: Acute coronary syndromeSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2019-002391-13-IT
• Lead Sponsor: AOU FEDERICO II

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-07
• Last Update Posted: 26 July 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

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 <30%) for non-ST-segment elevation ACS or ST-segment elevation myocardial infarction
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>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.