The GReek AntiPlatElet (GRAPE) Registry: A Multicenter Observational Prospective Investigation of Antiplatelet Treatment in Patients With Acute Coronary Syndrome Subjected to Percutaneous Coronary Intervention

Completed

• Conditions: Acute Coronary Syndrome

• Registration Number: NCT01774955
• Lead Sponsor: University of Patras

Brief Summary

This is a multicenter, prospective, observational investigation, focusing of antiplatelet treatment in patients with moderate to high risk acute coronary syndrome (TIMI risk score ≥3)subjected to percutaneous coronary intervention (PCI), being conducted in 7 PCI capable hospitals in Greece. Data concerning patients' demographic, clinical/procedural characteristics and contraindications/special warnings and precautions to P2Y12 inhibitors are collected during initial hospitalization. Study involves 3 follow-up visits after hospital discharge(Day 30, at 6 months and at 12 months) where data on major adverse cardiac events (death, myocardial infarction, stroke, urgent revascularization procedure with PCI or CABG), bleeding events(according to Bleeding Academic Research Consortium criteria)and adherence to antiplatelet treatment are collected.

In patients under ticagrelor or prasugrel treatment, platelet reactivity measurement with VerifyNow assay will be performed at Day 30

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2013-01-21
• Study First Submitted QC: 2013-01-21
• Study First Posted: 2013-01-24
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-19
• Last Update Posted: 2015-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2047

Inclusion Criteria

• Age>18 years
• Acute coronary syndrome moderate to high risk (TIMI risk score ≥3) subjected to PCI
• Informed consent

Exclusion Criteria

• Pregnancy/Breastfeeding
• Inability to give informed consent
• High probability of being unavailable for follow-up visits

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MACES at 12 months following PCI	12 months	The composite of death, myocardial infarction, stroke, urgent revascularization procedure with PCI or CABG at 12 months after PCI

Secondary Outcome Measures

Name	Time	Method
Any bleeding event (BARC classification) at 12 months after PCI	12 months	Any bleeding event (BARC classification) at 12 months after PCI

Trial Locations

Locations (9)

Iraklion University Hospital, Iraklion, Greece; 🇬🇷 Iraklion, Greece

Patras University Hospital; 🇬🇷 Patras, Achaia, Greece

Onassis Cardiac Surgery Center; 🇬🇷 Athens, Greece

University Hospital, Alexandroupolis; 🇬🇷 Alexandroupolis, Greece

Larissa University Hospital; 🇬🇷 Larissa, Greece

University Hospital, Ioannina; 🇬🇷 Ioannina, Greece

G.Gennimatas General Hospital; 🇬🇷 Athens, Attica, Greece

1st Department of Cardiology, Ippokration Hospital; 🇬🇷 Athens, Greece

Alexandra Hospital, Athens, Greece; 🇬🇷 Athens, Greece