EFFECTIVENESS OF AN ADDITIONAL LOAD WITH clopidogrel in patients on chronic clopidogrel TREATED WITH CORONARY ANGIOPLASITCA for acute coronary syndrome

prospective randomized ARMYDA RELOAD-ACS - ARMYDA_RELOAD_ACS

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005449-11-IT

Enrollment

200

Registered

2011-12-20

Start date

2011-11-08

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 ACS TREATED WITH coronary angioplasty MedDRA version: 14.1 Level: SOC Classification code 10007541 Term: Cardiac disorders System Organ Class: 10007541 - Cardiac disorders

Interventions

Trade Name: PLAVIX*4CPR RIV 300MG Pharmaceutical Form: Tablet INN or Proposed INN: CLOPIDOGREL SULFATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Unstable angina or myocardial infarction without ST-segment ELEVATION 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 150

Exclusion criteria

Exclusion criteria: 1. Patients undergoing primary coronary angioplasty for myocardial infarction with ST-segment sovraslivellamento 2. Patients with platelet counts below 70 × 109 / L 3. Patients undergoing surgery for coronary artery bypass graft in the previous three months 4. Patients with a recent episode of major bleeding (<6 months)

Design outcomes

Primary

Measure	Time frame
Main Objective: The purpose of the ARMYDA-RELOAD ACS is to examine whether in patients with NSTE-ACS already receiving chronic clopidogrel, a further loading dose of 600 mg administered before coronary angioplasty procedure might provide protection from cardiac ischemic complications with respect to dose standard 75 mg / day of clopidogrel.;Secondary Objective: ANTIPLATELET EFFICACY OF A FURTHER CLOPIDOGREL RELOAD;Primary end point(s): 30-day incidence of major adverse cardiac events (death, myocardial infarction or TARGET VESSEL revascularization);Timepoint(s) of evaluation of this end point: 30 DAYS	—

Measure

Time frame

Main Objective: The purpose of the ARMYDA-RELOAD ACS is to examine whether in patients with NSTE-ACS already receiving chronic clopidogrel, a further loading dose of 600 mg administered before coronary angioplasty procedure might provide protection from cardiac ischemic complications with respect to dose standard 75 mg / day of clopidogrel.;Secondary Objective: ANTIPLATELET EFFICACY OF A FURTHER CLOPIDOGREL RELOAD;Primary end point(s): 30-day incidence of major adverse cardiac events (death, myocardial infarction or TARGET VESSEL revascularization);Timepoint(s) of evaluation of this end point: 30 DAYS

—

Secondary

Measure	Time frame
Secondary end point(s): Evaluation of peri-procedural residual platelet reactivity, incidence of bleeding complications;Timepoint(s) of evaluation of this end point: 30 DAYS	—

Countries

Italy

Contacts

Public ContactUOC CARDIOLOGIA

UNIVERSITA' CAMPUS BIO-MEDICO DI ROMA

g.patti@unicampus.it06225411612

Outcome results

None listed

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