Prospective randomized ARMYDA 600x2 STUDY

Prospective randomized ARMYDA 600x2 STUDY - ARMYDA600X2

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-006210-13-IT

Enrollment

300

Registered

2012-03-07

Start date

2012-02-07

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 chronic stable angina candidates to coronary angioplasty MedDRA version: 14.1 Level: SOC Classification code 10007541 Term: Cardiac disorders System Organ Class: 10007541 - Cardiac disorders

Interventions

Trade Name: PLAVIX*28CPR RIV 75MG Pharmaceutical Form: Tablet INN or Proposed INN: CLOPIDOGREL SULFATE CAS Number: NA Current Sponsor code: NA Other descriptive name: NA Concentration unit: mg milligr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Patients with stable angina and inducible myocardial ischemia who are candidates for elective percutaneous 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 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200

Exclusion criteria

Exclusion criteria: ? Patients with acute coronary syndromes. ? Patients candidates to receive oral anticoagulant therapy. ? Patients with thrombocytopenia (platelets 2 mg / dl based. ? Patients with a recent episode of major bleeding (<6 months)

Design outcomes

Primary

Measure	Time frame
Main Objective: Incidence in both treatment arms of the combined endpoint of major adverse cardiac events at 30 days;Secondary Objective: ? Change in response to clopidogrel, assessed in terms of residual platelet reactivity ? Incidence of peri-procedural myocardial injury, defined as any increase in markers of post-angioplasty miocardionecrosi above the normal limit ? Incidence of bleeding complications according to the criteria TIMI (major bleeding: intracranial hemorrhage, or associated with a decrease in hemoglobin of 5 g / dL; minor bleeding: reduction of hemoglobin <5 g / dl) or access site complications;Primary end point(s): incidence of adverse cardiac events at 30 days;Timepoint(s) of evaluation of this end point: 30 days	—

Measure

Time frame

Main Objective: Incidence in both treatment arms of the combined endpoint of major adverse cardiac events at 30 days;Secondary Objective: ? Change in response to clopidogrel, assessed in terms of residual platelet reactivity ? Incidence of peri-procedural myocardial injury, defined as any increase in markers of post-angioplasty miocardionecrosi above the normal limit ? Incidence of bleeding complications according to the criteria TIMI (major bleeding: intracranial hemorrhage, or associated with a decrease in hemoglobin of 5 g / dL; minor bleeding: reduction of hemoglobin <5 g / dl) or access site complications;Primary end point(s): incidence of adverse cardiac events at 30 days;Timepoint(s) of evaluation of this end point: 30 days

—

Secondary

Measure	Time frame
Secondary end point(s): bleeding events;Timepoint(s) of evaluation of this end point: 30 days	—

Countries

Italy

Contacts

Public ContactCARDIOLOGIA

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