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

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

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndrome

• Study Type: Observational
• Enrollment (Actual): 2047

Contacts and Locations

Study Locations

• Greece
  • Alexandroupolis, Greece
    • University Hospital, Alexandroupolis
  • Athens, Greece
    • Onassis Cardiac Surgery Center
  • Athens, Greece
    • 1st Department of Cardiology, Ippokration Hospital
  • Athens, Greece
    • Alexandra Hospital, Athens, Greece
  • Ioannina, Greece
    • University Hospital, Ioannina
  • Iraklion, Greece
    • Iraklion University Hospital, Iraklion, Greece
  • Larissa, Greece
    • Larissa University Hospital
  • Achaia
    • Patras, Achaia, Greece, 26500
      • Patras University Hospital
  • Attica
    • Athens, Attica, Greece
      • G.Gennimatas General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Study population is consisted of patients with acute coronary syndrome subjected to PCI in 6 geographic regions of Greece

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACES at 12 months following PCI	The composite of death, myocardial infarction, stroke, urgent revascularization procedure with PCI or CABG at 12 months after PCI	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Any bleeding event (BARC classification) at 12 months after PCI	Any bleeding event (BARC classification) at 12 months after PCI	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of P2Y12 inhibitors (Clopidogrel, Prasugrel and Ticagrelor) use at 12 months following PCI	Rates of P2Y12 inhibitors (Clopidogrel, Prasugrel and Ticagrelor) use at 12 months following PCI	12 months
Any bleeding event (BARC classification) at 12 months after PCI	Any bleeding event (BARC classification) at 12 months after PCI between lowest and highest quartile of platelet reactivity value at Day 30	1 year

Collaborators and Investigators

• Sponsor: University of Patras
• Collaborators: Hellenic Cardiology Society

Publications and helpful links

General Publications

• Alexopoulos D, Vogiatzi C, Stavrou K, Vlassopoulou N, Perperis A, Pentara I, Xanthopoulou I. Diabetes mellitus and platelet reactivity in patients under prasugrel or ticagrelor treatment: an observational study. Cardiovasc Diabetol. 2015 May 30;14:68. doi: 10.1186/s12933-015-0232-1.
• Alexopoulos D, Stavrou K, Koniari I, Gkizas V, Perperis A, Kontoprias K, Vogiatzi C, Bampouri T, Xanthopoulou I. Ticagrelor vs prasugrel one-month maintenance therapy: impact on platelet reactivity and bleeding events. Thromb Haemost. 2014 Sep 2;112(3):551-7. doi: 10.1160/TH14-02-0119. Epub 2014 Jul 3.
• Alexopoulos D, Goudevenos JA, Xanthopoulou I, Deftereos S, Sitafidis G, Kanakakis I, Hamilos M, Parissis H, Ntalas IV, Angelidis C, Petousis S, Vavuranakis M, Hahalis G, Stefanadis C; GRAPE Investigators. Implementation of contemporary oral antiplatelet treatment guidelines in patients with acute coronary syndrome undergoing percutaneous coronary intervention: a report from the GReek AntiPlatelet rEgistry (GRAPE). Int J Cardiol. 2013 Oct 15;168(6):5329-35. doi: 10.1016/j.ijcard.2013.08.007. Epub 2013 Aug 15.

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: January 21, 2013
• First Submitted That Met QC Criteria: January 21, 2013
• First Posted (Estimate): January 24, 2013

Study Record Updates

• Last Update Posted (Estimate): August 20, 2015
• Last Update Submitted That Met QC Criteria: August 19, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome
• Other Study ID Numbers: GRAPE registry