The GReek AntiPlatElet (GRAPE) Registry: A Multicenter Obsrevational Prospective Investigation of Antiplatelet Treatment in Patients With Acute Coronary Syndrome Subjected to Percutaneous Coronary Intervention
This study is currently recruiting participants.
Verified January 2013 by University of Patras
Sponsor:
University of Patras
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: NA
Last verified: January 2013
History: No changes posted
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Purpose
This is a multicenter, prospective, observational investigation, focusing of antiplatelet treatment in patients with acute coronary syndrome subjected to percutaneous coronary intervention (PCI), being conducted in 7 PCI capable hospitals in Greece. Data conserning 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.
| 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 Obsrevational 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
| 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 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
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
| 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: | January 21, 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 May 16, 2013