Clinical trial NCT01774955: The GReek AntiPlatElet (GRAPE) Registry: A Multicenter Observational Prospective Investigation of Antiplatelet Treatment in Patients With Acute Coronary Syndrome Subjected to Percutaneous Coronary Intervention
Official title: The GReek AntiPlatElet (GRAPE) Registry: A Multicenter Observational Prospective Investigation of Antiplatelet Treatment in Patients With Acute Coronary Syndrome Subjected to Percutaneous Coronary Intervention
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Lead sponsor: University of Patras
Sponsor class: OTHER
Collaborators: name: Hellenic Cardiology Society
First posted: 2013-01-24
Enrollment: 2047
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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


Eligibility criteria: 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

Primary outcomes:
measure: MACES at 12 months following PCI
timeFrame: 12 months
Secondary outcomes:
measure: Any bleeding event (BARC classification) at 12 months after PCI
timeFrame: 12 months
Other outcomes:
measure: Rates of P2Y12 inhibitors (Clopidogrel, Prasugrel and Ticagrelor) use at 12 months following PCI
timeFrame: 12 months
measure: Any bleeding event (BARC classification) at 12 months after PCI
timeFrame: 1 year
Locations:
city: Patras
country: Greece
facility: Patras University Hospital
state: Achaia
city: Athens
country: Greece
facility: G.Gennimatas General Hospital
state: Attica
city: Alexandroupolis
country: Greece
facility: University Hospital, Alexandroupolis
city: Athens
country: Greece
facility: 1st Department of Cardiology, Ippokration Hospital
city: Athens
country: Greece
facility: Alexandra Hospital, Athens, Greece
city: Athens
country: Greece
facility: Onassis Cardiac Surgery Center
city: Ioannina
country: Greece
facility: University Hospital, Ioannina
city: Iraklion
country: Greece
facility: Iraklion University Hospital, Iraklion, Greece
city: Larissa
country: Greece
facility: Larissa University Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.