REGATTA-2: REGistry of Long-term AnTithrombotic TherApy-2
Sponsor
National Medical Research Center for Cardiology, Ministry of Health of Russian Federation (Other)
Overall Status
Recruiting
CT.gov ID
NCT04347187
Collaborator
(none)
2,000
1
131.5
15.2
Study Details
Study Description
Brief Summary
To assess the rates of ischemic and hemorrhagic complications of long-term antithrombotic therapy in patients with atrial fibrillation
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Detailed Description
The register is a Russian prospective single-center observational study of patients who have indications for long-term antithrombotic therapy in connection with atrial fibrillation
Study Design
Study Type:
Observational [Patient Registry]
Anticipated Enrollment
:
2000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Registry Dedicated to Assess the Risk of Ischemic and Hemorrhagic Complications of Long-term Antithrombotic Therapy in Patients With Atrial Fibrillation
Actual Study Start Date
:
Jan 15, 2015
Anticipated Primary Completion Date
:
Dec 31, 2025
Anticipated Study Completion Date
:
Dec 31, 2025
Outcome Measures
Primary Outcome Measures
- composite of major cardiovascular events [unclusion up to 5 years]
stroke, myocardial infarction, stent thrombosis [definite or probable], or urgent revascularization, cqrdiac death
- composite of any bleeding events [unclusion up to 5 years]
major, clinically relevant nonmajor, minor (BARC, ISTH,GARFIELD AF)
Secondary Outcome Measures
- Mutations in following genes [inclusion]
CYP2C9*, VKORC1
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Documented atrial fibrillation with CHA2DS2VASC > 1
Exclusion Criteria:
- Subjects who are unwilling or unable to provide informed consent. ACS within 12 months before inclusion Severe CHF (NYHA IV) Stroke within 6 months before inclusion Severe liver or muscle disease Severe kidney disease / renal failure with creatinine > 3 mg/dl Conceivable impossibility to come in touch with the patient or his family at 1-year after the intervention
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Medical Research Center for Cardiology, Ministry of Health of Russian Federation | Moscow | Russian Federation | 121552 |
Sponsors and Collaborators
- National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
Investigators
- Principal Investigator: Elizaveta Panchenko, PhD, National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
Study Documents (Full-Text)
None provided.More Information
Publications
- Olsen AS, McGettigan P, Gerds TA, Fosbøl EL, Olesen JB, Sindet-Pedersen C, Staerk L, Lock Hansen M, Pallisgaard JL, Køber L, Torp-Pedersen C, Gislason GH, Lamberts M. Risk of gastrointestinal bleeding associated with oral anticoagulation and non-steroidal anti-inflammatory drugs in patients with atrial fibrillation: a nationwide study. Eur Heart J Cardiovasc Pharmacother. 2020 Sep 1;6(5):292-300. doi: 10.1093/ehjcvp/pvz069.
- Panchenko E, Kropacheva E, Dobrovolsky A, Titaeva E, Zemlyanskaya O, Trofimov D, Galkina I, Lifshits G, Vereina N, Sinitsin S, Vorobyeva N, Grehova L, Zateyshchikov D, Zotova I, Vavilova T, Sirotkina O, Grontkovskaya A. CYP2C9 and VKORC1 genotyping for the quality of long-standing warfarin treatment in Russian patients. Pharmacogenomics J. 2020 Oct;20(5):687-694. doi: 10.1038/s41397-020-0157-2. Epub 2020 Feb 6.
- van Rein N, Heide-Jørgensen U, Lijfering WM, Dekkers OM, Sørensen HT, Cannegieter SC. Major Bleeding Rates in Atrial Fibrillation Patients on Single, Dual, or Triple Antithrombotic Therapy. Circulation. 2019 Feb 5;139(6):775-786. doi: 10.1161/CIRCULATIONAHA.118.036248.
Responsible Party:
Elizaveta Panchenko,
professor,
National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
ClinicalTrials.gov Identifier:
NCT04347187
Other Study ID Numbers:
- REGATTA203121975
First Posted:
Apr 15, 2020
Last Update Posted:
Apr 15, 2020
Last Verified:
Apr 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Elizaveta Panchenko,
professor,
National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
Additional relevant MeSH terms: