Clopidogrel Reloading in Patients With NSTEACS Undergoing Percutaneous Coronary Intervention on Chronic Clopidogrel Therapy
Patients who developed an acute coronary syndrome despite dual antiplatelet therapy with aspirin and clopidogrel may benefit from a further dose of clopidogrel before a percutaneous coronary intervention.
The aim of this study is to evaluate safety and effectiveness of clopidogrel reloading in patients on chronic clopidogrel therapy with acute coronary syndrome undergoing percutaneous coronary intervention.
Acute Coronary Syndrome
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
|Official Title:||Clopidogrel Reloading in Patients With Non-ST Elevation Acute Coronary Syndrome Undergoing PCI on Chronic Clopidogrel Therapy. Results of the ARMYDA RELOAD ACS (Antiplatelet Therapy for Reduction of MYocardial Damage During Angioplasty in Acute Coronary Syndrome) Randomized Trial.|
- Major Adverse Cardiovascular Events [ Time Frame: 30 days ] [ Designated as safety issue: No ]Death Myocardial Infarction Target Vessel Revascularization
- Bleeding Events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]Occurrence of vascular/bleeding complications, defined as: (a) major bleeding (intracranial bleeding or clinically overt bleeding associated with a decrease in haemoglobin >5 g/dL, according to the TIMI criteria); (b) minor bleeding (clinically overt haemorrhage associated with a fall in haemoglobin ≤5 g/dL); (c) entry-site complications (haematoma >5 cm, pseudoaneurysm or arteriovenous fistula)
- Grade of platelet residual reactivity [ Time Frame: Immediately before PCI (4-6h after randomization), 8h and 24h after PCI ] [ Designated as safety issue: No ]
Patient's response to clopidogrel at 3 different timing, assessed with VerifyNow P2Y12 Assays.
The first timing is immediately before PCI (4-6h after randomization), once accomplished the diagnostic angiogram.
The second and third timings are, respectively, 8h and 24h after PCI.
|Study Start Date:||November 2011|
|Estimated Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
600 mg of clopidogrel loading dose 6-8 h before coronary angiogram, in addition to the chronic daily dose of 75 mg
600 mg clopidogrel loading dose 6-8 h before diagnostic coronary angiogram
Other Name: Plavix
Placebo Comparator: Placebo
Placebo arm in addition to the chronic daily dose of 75 mg
Placebo in addition to the chronic daily dose of 75 mg
|Contact: Giuseppe Patti, MDfirstname.lastname@example.org|
|Vito Fazzi Hospital||Recruiting|
|Lecce, Italy, 73100|
|Principal Investigator: Giuseppe Colonna, MD|
|Sub-Investigator: Antonio Montinaro, MD|
|Campus Bio-Medico University||Recruiting|
|Rome, Italy, 00128|
|Principal Investigator: Giuseppe Patti, MD|
|Sub-Investigator: Vincenzo Vizzi, MD|
|Sub-Investigator: Elisabetta Ricottini, MD|
|Sub-Investigator: Fabio Mangiacapra, MD|
|Principal Investigator:||Giuseppe Patti, MD||Campus Bio-Medico University|