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

Acute Coronary Syndrome Clinical Trial

— GRAPE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01774955
• Other study ID #: GRAPE registry
• Status: Completed
• Phase: N/A
• First received: January 21, 2013
• Last updated: August 19, 2015
• Start date: February 2012
• Est. completion date: December 2014

Study information

• Verified date: August 2015
• Source: University of Patras
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2047
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of Patras	Hellenic Cardiological Society

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	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	Yes
Primary	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	No
Secondary	Any bleeding event (BARC classification) at 12 months after PCI	Any bleeding event (BARC classification) at 12 months after PCI	12 months	Yes