NCT01774955

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,047

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2012

Typical duration for all trials

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 24, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

August 20, 2015

Status Verified

August 1, 2015

Enrollment Period

2.8 years

First QC Date

January 21, 2013

Last Update Submit

August 19, 2015

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

  • MACES at 12 months following PCI

    The composite of death, myocardial infarction, stroke, urgent revascularization procedure with PCI or CABG at 12 months after PCI

    12 months

Secondary Outcomes (1)

  • Any bleeding event (BARC classification) at 12 months after PCI

    12 months

Other Outcomes (2)

  • Rates of P2Y12 inhibitors (Clopidogrel, Prasugrel and Ticagrelor) use at 12 months following PCI

    12 months

  • Any bleeding event (BARC classification) at 12 months after PCI

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Age\>18 years
  • Acute coronary syndrome moderate to high risk (TIMI risk score ≥3) subjected to PCI
  • Informed consent

You may not qualify if:

  • Pregnancy/Breastfeeding
  • Inability to give informed consent
  • High probability of being unavailable for follow-up visits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Patras University Hospital

Pátrai, Achaia, 26500, Greece

Location

G.Gennimatas General Hospital

Athens, Attica, Greece

Location

University Hospital, Alexandroupolis

Alexandroupoli, Greece

Location

1st Department of Cardiology, Ippokration Hospital

Athens, Greece

Location

Alexandra Hospital, Athens, Greece

Athens, Greece

Location

Onassis Cardiac Surgery Center

Athens, Greece

Location

University Hospital, Ioannina

Ioannina, Greece

Location

Iraklion University Hospital, Iraklion, Greece

Irakleio, Greece

Location

Larissa University Hospital

Larissa, Greece

Location

Related Publications (3)

  • Alexopoulos D, Vogiatzi C, Stavrou K, Vlassopoulou N, Perperis A, Pentara I, Xanthopoulou I. Diabetes mellitus and platelet reactivity in patients under prasugrel or ticagrelor treatment: an observational study. Cardiovasc Diabetol. 2015 May 30;14:68. doi: 10.1186/s12933-015-0232-1.

    PMID: 26025572DERIVED

  • Alexopoulos D, Stavrou K, Koniari I, Gkizas V, Perperis A, Kontoprias K, Vogiatzi C, Bampouri T, Xanthopoulou I. Ticagrelor vs prasugrel one-month maintenance therapy: impact on platelet reactivity and bleeding events. Thromb Haemost. 2014 Sep 2;112(3):551-7. doi: 10.1160/TH14-02-0119. Epub 2014 Jul 3.

    PMID: 24990396DERIVED

  • 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.

    PMID: 23978364DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Cardiology

Study Record Dates

First Submitted

January 21, 2013

First Posted

January 24, 2013

Study Start

February 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

August 20, 2015

Record last verified: 2015-08

Locations

GR(9)