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 has been completed.
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 19, 2015
Last verified: August 2015
  Purpose

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
Acute Coronary Syndrome

Study Type: Observational [Patient Registry]
Study Design: 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

Further study details as provided by University of Patras:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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


Enrollment: 2047
Study Start Date: February 2012
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01774955

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

No publications provided by University of Patras

Additional 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
Study First Received: January 21, 2013
Last Updated: August 19, 2015
Health Authority: Greece: Ethics Committee

Additional relevant MeSH terms:
Acute Coronary Syndrome
Syndrome
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Disease
Heart Diseases
Myocardial Ischemia
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on August 31, 2015