study to evaluate the clinical benefit of administering clopidogrel loading dose prior to the procedure of coronary angioplasty

prospective randomized study Armyda Pro 240 - ARMYDA PRO 240

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005095-41-IT

Enrollment

300

Registered

2011-12-23

Start date

2011-09-27

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 treated with clopidogrel candidates for coronary angioplasty for ST-segment elevation acute coronary syndrome or stable angina MedDRA version: 14.1 Level: SOC Classification code 10007541 Term: Cardiac disorders System Organ Class: 10007541 - Cardiac disorders

Interventions

Trade Name: CLOPIDOGREL WINTH.*50x1CPR 75M Pharmaceutical Form: Film-coated tablet INN or Proposed INN: CLOPIDOGREL SULFATE Concentration unit: mg milligram(s) Concentration type: up to Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with stable angina, myocardial ischemia and inducible indication to perform coronary angiography, or 2. Patients with NSTE-ACS (unstable angina or myocardial infarction without ST-segment overlined) that require an 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 250

Exclusion criteria

Exclusion criteria: 1. Patients who require primary angioplasty for myocardial infarction with ST-segment overlined 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: prevention of major adverse cardiac events in patients undergoing coronary angioplasty;Secondary Objective: Evaluation of peri-procedural residual platelet reactivity;incidence of peri-procedural myocardial injury; Incidence of bleeding complications.;Primary end point(s): 30-day incidence of coronary dall'angioplastica major adverse cardiac events (death, myocardial infarction or revascularization new "target") and in patients enrolled in the registry than in those randomized. The peri-procedural myocardial infarction is defined as an increase in post-angioplasty values ??of CK-MB> 3 times normal.;Timepoint(s) of evaluation of this end point: 30 days	—

Measure

Time frame

Main Objective: prevention of major adverse cardiac events in patients undergoing coronary angioplasty;Secondary Objective: Evaluation of peri-procedural residual platelet reactivity;incidence of peri-procedural myocardial injury; Incidence of bleeding complications.;Primary end point(s): 30-day incidence of coronary dall'angioplastica major adverse cardiac events (death, myocardial infarction or revascularization new "target") and in patients enrolled in the registry than in those randomized. The peri-procedural myocardial infarction is defined as an increase in post-angioplasty values ??of CK-MB> 3 times normal.;Timepoint(s) of evaluation of this end point: 30 days

—

Secondary

Measure	Time frame
Secondary end point(s): 1. Evaluation of peri-procedural residual platelet reactivity 2. Incidence of peri-procedural myocardial injury, defined as any increase in markers of post-angioplasty miocardionecrosi above the normal limit 3. Incidence of bleeding complications according to TIMI criteria;Timepoint(s) of evaluation of this end point: 30 days	—

Countries

Italy

Contacts

Public ContactArea di Cardiologia

Universita' Campus Bio-Medico

g.patti@unicampus.it3481324846

Outcome results

None listed

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