Prospective randomized study on antiplatelet treatment in patients with acute myocardial infarction with ST elevation

Prospective randomized study ARMYDA PRIME

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-003423-37-IT

Enrollment

200

Registered

2012-08-02

Start date

2012-07-31

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

patients with acute myocardial infarction with ST elevation (STEMI) 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: Tablet CAS Number: 150322-43-3 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Trade Name: BRILIQUE*56CP

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: patients with STEMI who are candidates for early invasive strategy 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 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100

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)

Design outcomes

Primary

Measure	Time frame
Main Objective: COMPARING THE EFFICACY AND SAFETY ticagrelor AGAINST prasugrel in STEMI;Secondary Objective: ASSESSING THE IMPACT OF A CLINICAL 30 DAYS;Primary end point(s): evaluating the extent of infarction, defined as the area under the curve of CK-MB and troponin-I, calculated by linear trapezoidal method;Timepoint(s) of evaluation of this end point: BEFORE PCI, 4, 8,12,24, 36, 48 and 72 hours after PCI	—

Measure

Time frame

Main Objective: COMPARING THE EFFICACY AND SAFETY ticagrelor AGAINST prasugrel in STEMI;Secondary Objective: ASSESSING THE IMPACT OF A CLINICAL 30 DAYS;Primary end point(s): evaluating the extent of infarction, defined as the area under the curve of CK-MB and troponin-I, calculated by linear trapezoidal method;Timepoint(s) of evaluation of this end point: BEFORE PCI, 4, 8,12,24, 36, 48 and 72 hours after PCI

—

Secondary

Measure	Time frame
Secondary end point(s): 1. Prevalence of coronary TIMI flow grade> 1 prior to PCI and <3 after PCI 2. Left ventricular ejection fraction assessed by echocardiography pre-discharge 3. Incidence of major cardiovascular events at 30 days 4. Incidence of bleeding events / complications of the access site at 30 days;Timepoint(s) of evaluation of this end point: 1. BEFORE AND AFTER PCI 2. PRE DISCHARGE 3. 30 DAYS 4. 30 DAYS	—

Measure

Time frame

Secondary end point(s): 1. Prevalence of coronary TIMI flow grade> 1 prior to PCI and <3 after PCI 2. Left ventricular ejection fraction assessed by echocardiography pre-discharge 3. Incidence of major cardiovascular events at 30 days 4. Incidence of bleeding events / complications of the access site at 30 days;Timepoint(s) of evaluation of this end point: 1. BEFORE AND AFTER PCI 2. PRE DISCHARGE 3. 30 DAYS 4. 30 DAYS

—

Countries

Italy

Contacts

Public ContactCARDIOLOGIA

UNIVERSITA' CAMPUS BIO-MEDICO DI ROMA

g.patti@unicampus.it06225411143

Outcome results

None listed

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