Comparison of two antiplatelet agents in patients with acute coronary syndrome.

PRAsugrel versus TICagrelor for platelet inhibition in patients with non-ST segment elevation acute coronary syndrome (PRATIC) - PRATIC

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-002404-41-IT

Enrollment

100

Registered

2012-08-10

Start date

2012-07-03

Completion date

Unknown

Last updated

2014-01-27

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: 14.1 Level: SOC Classification code 10007541 Term: Cardiac disorders System Organ Class: 10007541 - Cardiac disorders

Interventions

Trade Name: EFIENT*28CPR RIV 10MG Pharmaceutical Form: Coated tablet INN or Proposed INN: PRASUGREL HYDROCHLORIDE CAS Number: 389574-19-0 Concentration unit: mg milligram(s) Concentration type: equal

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with ACS who require treatment with coronary angioplasty Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: 1. Patients over 75 years of age 2. Patients weighing under 65 kg 3. Patients with previous cerebrovascular events 4. Patients with platelet counts below 70 × 109 / L 5. Patients undergoing surgery for aorto-coronary bypass in the previous three months 6. Patients with a recent episode of major bleeding (<6 months) 7. Patients treated with inhibitors of the platelet P2Y12 receptor in the previous 7 days

Design outcomes

Primary

Measure	Time frame
Main Objective: assessment of residual platelet reactivity at time of coronary angioplasty;Secondary Objective: 1. Evaluation of platelet reactivity 24 hours after the angioplasty procedure; 2. Incidence of periprocedural infarction; 3. Incidence of adverse events at 30 days.;Primary end point(s): Evaluation of residual platelet reactivity by use of the VerifyNow P2Y12 Assay;Timepoint(s) of evaluation of this end point: before the angioplasty procedure, 8 hours and 24 hours after the procedure	—

Measure

Time frame

Main Objective: assessment of residual platelet reactivity at time of coronary angioplasty;Secondary Objective: 1. Evaluation of platelet reactivity 24 hours after the angioplasty procedure; 2. Incidence of periprocedural infarction; 3. Incidence of adverse events at 30 days.;Primary end point(s): Evaluation of residual platelet reactivity by use of the VerifyNow P2Y12 Assay;Timepoint(s) of evaluation of this end point: before the angioplasty procedure, 8 hours and 24 hours after the procedure

—

Secondary

Measure	Time frame
Secondary end point(s): dose of miocardionecrosi markers (CK-MB and Troponin I);Timepoint(s) of evaluation of this end point: before the angioplasty procedure, 8 hours and 24 hours after the procedure	—

Countries

Italy

Contacts

Public ContactCARDIOLOGIA

POLICLINICO UNIVERSITARIO CAMPUS BIO-MEDICO

f.mangiacapra@unicampus.it003906225411662

Outcome results

None listed

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