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. (see Contacts and Locations)
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
  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


Estimated Enrollment: 2000
Study Start Date: February 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 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

Contacts
Contact: Dimitrios Alexopoulos, MD dalex@med.upatras.gr

Locations
Greece
Patras University Hospital Recruiting
Patras, Achaia, Greece, 26500
Principal Investigator: Dimitrios Alexopoulos, MD         
G.Gennimatas General Hospital Recruiting
Athens, Attica, Greece
Principal Investigator: Spyridon Deftereos, MD         
University Hospital, Alexandroupolis Recruiting
Alexandroupolis, Greece
Principal Investigator: Stavros Konstantinides, MD         
Alexandra Hospital, Athens, Greece Recruiting
Athens, Greece
Principal Investigator: Ioannis Kanakakis, MD         
1st Department of Cardiology, Ippokration Hospital Recruiting
Athens, Greece
Principal Investigator: Christodoulos Stefanadis, MD         
Onassis Cardiac Surgery Center Recruiting
Athens, Greece
Principal Investigator: Vasileios Voudris, MD         
University Hospital, Ioannina Recruiting
Ioannina, Greece
Principal Investigator: Ioannis Goudevenos, MD         
Iraklion University Hospital, Iraklion, Greece Recruiting
Iraklion, Greece
Principal Investigator: Panos Vardas, MD         
Larissa University Hospital Recruiting
Larissa, Greece
Principal Investigator: Filippos Tryposkiadis, MD         
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 1, 2013
Health Authority: Greece: Ethics Committee

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

ClinicalTrials.gov processed this record on August 21, 2014