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OpenTrials
Completed

NCT Number: NCT01774955

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

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Patras University Hospital, Pátrai, Achaia, Greece

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Patras

Other

Collaborators

  • Hellenic Cardiology Society

Registry information

Acronym: GRAPE

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jan 24, 2013
Registry last updated
Aug 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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