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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01774955
Recruitment Status : Completed
First Posted : January 24, 2013
Last Update Posted : August 20, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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


Condition or disease
Acute Coronary Syndrome

Study Design

Study Type : Observational [Patient Registry]
Actual Enrollment : 2047 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
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 Start Date : February 2012
Primary Completion Date : December 2014
Study Completion Date : December 2014
Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. MACES at 12 months following PCI [ Time Frame: 12 months ]
    The composite of death, myocardial infarction, stroke, urgent revascularization procedure with PCI or CABG at 12 months after PCI


Secondary Outcome Measures :
  1. Any bleeding event (BARC classification) at 12 months after PCI [ Time Frame: 12 months ]
    Any bleeding event (BARC classification) at 12 months after PCI


Other Outcome Measures:
  1. Rates of P2Y12 inhibitors (Clopidogrel, Prasugrel and Ticagrelor) use at 12 months following PCI [ Time Frame: 12 months ]
    Rates of P2Y12 inhibitors (Clopidogrel, Prasugrel and Ticagrelor) use at 12 months following PCI

  2. Any bleeding event (BARC classification) at 12 months after PCI [ Time Frame: 1 year ]
    Any bleeding event (BARC classification) at 12 months after PCI between lowest and highest quartile of platelet reactivity value at Day 30


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01774955


Locations
Greece
Patras University Hospital
Patras, Achaia, Greece, 26500
G.Gennimatas General Hospital
Athens, Attica, Greece
University Hospital, Alexandroupolis
Alexandroupolis, Greece
1st Department of Cardiology, Ippokration Hospital
Athens, Greece
Alexandra Hospital, Athens, Greece
Athens, Greece
Onassis Cardiac Surgery Center
Athens, Greece
University Hospital, Ioannina
Ioannina, Greece
Iraklion University Hospital, Iraklion, Greece
Iraklion, Greece
Larissa University Hospital
Larissa, Greece
Sponsors and Collaborators
University of Patras
Hellenic Cardiological Society
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dimitrios Alexopoulos, Professor of Cardiology, University of Patras
ClinicalTrials.gov Identifier: NCT01774955     History of Changes
Other Study ID Numbers: GRAPE registry
First Posted: January 24, 2013    Key Record Dates
Last Update Posted: August 20, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Syndrome
Acute Coronary Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases