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

This study is currently recruiting participants.
Verified August 2013 by University of Patras
Sponsor:
Collaborator:
Hellenic Cardiological Society
Information provided by (Responsible Party):
Dimitrios Alexopoulos, University of Patras
ClinicalTrials.gov Identifier:
NCT01774955
First received: January 21, 2013
Last updated: August 1, 2013
Last verified: August 2013

January 21, 2013
August 1, 2013
February 2012
February 2014   (final data collection date for primary outcome measure)
MACES at 12 months following PCI [ Time Frame: 12 months ] [ Designated as safety issue: No ]
The composite of death, myocardial infarction, stroke, urgent revascularization procedure with PCI or CABG at 12 months after PCI
Same as current
Complete list of historical versions of study NCT01774955 on ClinicalTrials.gov Archive Site
Any bleeding event (BARC classification) at 12 months after PCI [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Any bleeding event (BARC classification) at 12 months after PCI
Same as current
  • Rates of P2Y12 inhibitors (Clopidogrel, Prasugrel and Ticagrelor) use at 12 months following PCI [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Rates of P2Y12 inhibitors (Clopidogrel, Prasugrel and Ticagrelor) use at 12 months following PCI
  • Any bleeding event (BARC classification) at 12 months after PCI [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Any bleeding event (BARC classification) at 12 months after PCI between lowest and highest quartile of platelet reactivity value at Day 30
Rates of P2Y12 inhibitors (Clopidogrel, Prasugrel and Ticagrelor) use at 12 months following PCI [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Rates of P2Y12 inhibitors (Clopidogrel, Prasugrel and Ticagrelor) use at 12 months following PCI
 
The GReek AntiPlatElet (GRAPE) Registry: A Multicenter Observational Prospective Investigation of Antiplatelet Treatment in Patients With Acute Coronary Syndrome Subjected to Percutaneous Coronary Intervention
The GReek AntiPlatElet (GRAPE) Registry: A Multicenter Observational Prospective Investigation of Antiplatelet Treatment in Patients With Acute Coronary Syndrome Subjected to Percutaneous Coronary Intervention

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

Not Provided
Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
12 Months
Not Provided
Probability Sample

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

Acute Coronary Syndrome
Not Provided
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2000
February 2014
February 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Dimitrios Alexopoulos, MD dalex@med.upatras.gr
Greece
 
NCT01774955
GRAPE registry
No
Dimitrios Alexopoulos, University of Patras
University of Patras
Hellenic Cardiological Society
Not Provided
University of Patras
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP