Acute Coronary SyndromeGRAPENCT01774955
The GReek AntiPlatElet (GRAPE) Registry: A Multicenter Observational Prospective Investigation of Antiplatelet Treatment in Patients With Acute Coronary Syndrome Subjected to Percutaneous Coronary Intervention
An observational study of Acute Coronary Syndrome, run by University of Patras at 9 sites in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 2,047 participants
- Where
- 9 sitesGreece
- Study dates
- Feb 2012to Dec 2014
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population is consisted of patients with acute coronary syndrome subjected to PCI in 6 geographic regions of Greece
Who may be able to join
- Age>18 years
- Acute coronary syndrome moderate to high risk (TIMI risk score ≥3) subjected to PCI
- Informed consent
Who cannot join
- Pregnancy/Breastfeeding
- Inability to give informed consent
- High probability of being unavailable for follow-up visits
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Greece9 sites
University Hospital, Alexandroupolis
Alexandroupoli
G.Gennimatas General Hospital
Athens, Attica
1st Department of Cardiology, Ippokration Hospital
Athens
Alexandra Hospital, Athens, Greece
Athens
Onassis Cardiac Surgery Center
Athens
University Hospital, Ioannina
Ioannina
Iraklion University Hospital, Iraklion, Greece
Irakleio
Larissa University Hospital
Larissa
Patras University Hospital
Pátrai, Achaia, 26500
About this study
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
- Conditions
- Acute Coronary Syndrome
- Medical subject headings
- Acute Coronary Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (1)
Any bleeding event (BARC classification) at 12 months after PCI
Any bleeding event (BARC classification) at 12 months after PCI
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2013 (estimated)
- Study startFeb 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,047 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University of Patras
- Sponsor type
- University, hospital or other
- Collaborators
- Hellenic Cardiology Society
- Responsible party
- Principal investigator, Dimitrios Alexopoulos, University of Patras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01774955
- Sponsor's protocol ID
- GRAPE registry
- Acronym
- GRAPE
- Status last verified
- Aug 2015
- First submitted
- 21 Jan 2013
- Last updated
- 20 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26025572Alexopoulos 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.
PubMed 24990396Alexopoulos 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.
PubMed 23978364
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01774955
- Acronym / sponsor ID
- GRAPE / GRAPE registry
- Conditions
- Acute Coronary Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,047 participants (actual)
- Lead sponsor
- University of PatrasUniversity, hospital or other
- Collaborators
- Hellenic Cardiology Society
- Study start
- Feb 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 24 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population is consisted of patients with acute coronary syndrome subjected to PCI in 6 geographic regions of Greece
Key inclusion criteria (3 listed)
- Age>18 years
- Acute coronary syndrome moderate to high risk (TIMI risk score ≥3) subjected to PCI
- Informed consent
Key exclusion criteria (3 listed)
- Pregnancy/Breastfeeding
- Inability to give informed consent
- High probability of being unavailable for follow-up visits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Any bleeding event (BARC classification) at 12 months after PCI
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2015.
- Derived from this study: PubMed 26025572Alexopoulos 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.
- Derived from this study: PubMed 24990396Alexopoulos 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.
- Derived from this study: PubMed 23978364Alexopoulos 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by University of Patras at 9 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACES at 12 months following PCI (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01774955, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2015.