Ignite Creation Date:
2024-05-06 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04695106
Status:
RECRUITING
Last Update Posted:
2021-11-04
First Post:
2020-11-25
Brief Title:
Dual Antithrombotic Therapy With Dabigatran and Ticagrelor in Patients With ACS and Non-valvular AF Undergoing PCI
Sponsor:
Medical University of Gdansk
Organization:
Medical University of Gdansk
Study Overview
Official Title:
Dual Antithrombotic Therapy With Dabigatran and Ticagrelor in Patients With Acute Coronary Syndrome and Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention ADONIS-PCI
Status:
RECRUITING
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ADONIS-PCI
Brief Summary:
More than 25 of patients referred for diagnostic coronary angiography and percutaneous coronary intervention PCI due to acute coronary syndrome ACS suffer from non-valvular atrial fibrillation AF In this particular setting balancing between the prevention of thrombosis and the risk of bleeding remains challenging Oral anticoagulation OAC prevents stroke and systemic embolism but has not been shown to prevent stent thrombosis ST Dual antiplatelet therapy DAPT reduces the incidence of recurrent ischemic events and ST but is less effective in reducing the incidence of cardioembolic stroke associated with AF A common guideline-supported practice is to combine three drugs OAC aspirin and clopidogrel in a triple therapy which is associated with high annual risk up to 25 of major bleeding Thus new therapeutic strategies are urgently needed to maintain the efficacy while improving the safety of treatment in patients with AF and ACS undergoing PCI
This is a prospective randomized open-label blinded-endpoint non-inferiority trial 2230 patients with non-valvular AF that had undergone successful PCI due to an ACS within the previous 72 hours will be randomized in 11 ratio to receive one of the two treatments dual therapy with dabigatran 150 mg twice daily or 110 mg twice daily and ticagrelor 90 mg twice daily for 1 month followed by 60 mg twice daily up to 12 months or standard therapy according to current guidelines triple therapy with dabigatran 150 mg bid or 110 mg bid plus clopidogrel 75 mg od plus aspirin 75 mg od followed by double therapy depending on the bleeding and ischaemic risk Study treatment will be continued for 12 months The primary study end-point is the first major or clinically relevant non-major bleeding event per ISTH in a time-to-event analysis The main secondary end-point is a composite efficacy end-point of thromboembolic events myocardial infarction stroke or systemic embolism death or unplanned revascularization PCI or coronary artery bypass grafting at 12 months
We expect that dual antithrombotic therapy including reduced dose ticagrelor and dabigatran is at least non-inferior regarding bleeding risk and ischaemic protection compared to the standard triple therapy in patients with AF and after ACS treated with PCI
This is a prospective randomized open-label blinded-endpoint non-inferiority trial 2230 patients with non-valvular AF that had undergone successful PCI due to an ACS within the previous 72 hours will be randomized in 11 ratio to receive one of the two treatments dual therapy with dabigatran 150 mg twice daily or 110 mg twice daily and ticagrelor 90 mg twice daily for 1 month followed by 60 mg twice daily up to 12 months or standard therapy according to current guidelines triple therapy with dabigatran 150 mg bid or 110 mg bid plus clopidogrel 75 mg od plus aspirin 75 mg od followed by double therapy depending on the bleeding and ischaemic risk Study treatment will be continued for 12 months The primary study end-point is the first major or clinically relevant non-major bleeding event per ISTH in a time-to-event analysis The main secondary end-point is a composite efficacy end-point of thromboembolic events myocardial infarction stroke or systemic embolism death or unplanned revascularization PCI or coronary artery bypass grafting at 12 months
We expect that dual antithrombotic therapy including reduced dose ticagrelor and dabigatran is at least non-inferior regarding bleeding risk and ischaemic protection compared to the standard triple therapy in patients with AF and after ACS treated with PCI
Detailed Description:
Health problem More than 25 of patients referred for diagnostic coronary angiography and percutaneous coronary intervention PCI due to acute coronary syndrome ACS suffer from non-valvular atrial fibrillation AF In this particular setting balancing between the prevention of thrombosis and the risk of bleeding remains challenging Oral anticoagulation OAC prevents stroke and systemic embolism but does not prevent stent thrombosis Dual antiplatelet therapy DAPT reduces the incidence of recurrent ischemic events and stent thrombosis but is less effective in reducing the incidence of cardioembolic stroke associated with AF A common guideline-supported practice is to combine all three drugs OAC aspirin and clopidogrel in triple therapy but this approach remains an expert opinion Moreover triple therapy is associated with a high annual risk up to 25 of major bleeding Thus new therapeutic strategies are urgently needed to maintain efficacy while improving treatment safety in patients with AF and ACS undergoing PCI The investigators hypothesize that dual antithrombotic therapy including reduced dose ticagrelor study group n1115 is non-inferior regarding bleeding risk and ischaemic protection to the standard triple therapy control group n1115 in patients with AF and treated with PCI due to ACS
Study population The studys target population is male and female patients aged 18 years with non-valvular AF that underwent a successful PCI due to an ACS AF may be paroxysmal persistent or permanent but must not be secondary to a reversible disorder such as myocardial infarction pulmonary embolism recent surgery pericarditis or thyrotoxicosis ACS may be ST-elevation myocardial infarction STEMI non-STEMI NSTEMI or unstable angina UA
Study design This is a multicentre prospective randomized open-label blinded endpoint non-inferiority trial Within 72 hours post PCI patients will be randomized in a 11 ratio to receive one of the two treatments dual therapy with ticagrelor 90 mg twice daily for one month followed by 60 mg twice daily up to 12 months plus dabigatran 150 mg twice daily or 110 mg twice daily standard of care or triple therapy with clopidogrel 75 mg once daily plus aspirin 75 mg once daily plus dabigatran 150 mg twice daily or 110 mg twice daily according to current guidelines Study treatment will be continued for 12 months
Endpoints The primary study endpoint is the first major or clinically relevant non-major bleeding event as defined by the International Society on Thrombosis and Haemostasis ISTH in a time-to-event analysis The main secondary endpoint is a composite efficacy endpoint of thromboembolic events myocardial infarction stroke or systemic embolism death or unplanned revascularization PCI or coronary artery bypass grafting
Expected results The investigators expect that the off-label regimen of dual antithrombotic therapy including reduced dose ticagrelor is at least non-inferior regarding bleeding risk and ischaemic protection to the standard triple therapy in patients with AF and after ACS treated with PCI
Discussion The investigators propose a new off-label treatment regimen which is reduced dose ticagrelor in patients with AF and ACS The most scientifically valuable points of the proposed project are the first-ever i attempt to administer the off-label potent P2Y12 inhibitor ticagrelor as a part of dual antiplatelet therapy in patients with AF and ACS and ii evaluation of the reduced dose of ticagrelor in the setting of ACS The three most innovative aspects are i new treatment regimen with a reduced ticagrelor dose in ACS setting ii possibility to introduce the polypill containing ticagrelor and dabigatran to the Polish market and iii potential manufacture of the polypill containing various doses of ticagrelor and dabigatran depending on the patients individual ischaemic and bleeding risk If successful the proposed study will answer the burning clinical question about the optimal treatment strategy in patients with AF and ACS
Study population The studys target population is male and female patients aged 18 years with non-valvular AF that underwent a successful PCI due to an ACS AF may be paroxysmal persistent or permanent but must not be secondary to a reversible disorder such as myocardial infarction pulmonary embolism recent surgery pericarditis or thyrotoxicosis ACS may be ST-elevation myocardial infarction STEMI non-STEMI NSTEMI or unstable angina UA
Study design This is a multicentre prospective randomized open-label blinded endpoint non-inferiority trial Within 72 hours post PCI patients will be randomized in a 11 ratio to receive one of the two treatments dual therapy with ticagrelor 90 mg twice daily for one month followed by 60 mg twice daily up to 12 months plus dabigatran 150 mg twice daily or 110 mg twice daily standard of care or triple therapy with clopidogrel 75 mg once daily plus aspirin 75 mg once daily plus dabigatran 150 mg twice daily or 110 mg twice daily according to current guidelines Study treatment will be continued for 12 months
Endpoints The primary study endpoint is the first major or clinically relevant non-major bleeding event as defined by the International Society on Thrombosis and Haemostasis ISTH in a time-to-event analysis The main secondary endpoint is a composite efficacy endpoint of thromboembolic events myocardial infarction stroke or systemic embolism death or unplanned revascularization PCI or coronary artery bypass grafting
Expected results The investigators expect that the off-label regimen of dual antithrombotic therapy including reduced dose ticagrelor is at least non-inferior regarding bleeding risk and ischaemic protection to the standard triple therapy in patients with AF and after ACS treated with PCI
Discussion The investigators propose a new off-label treatment regimen which is reduced dose ticagrelor in patients with AF and ACS The most scientifically valuable points of the proposed project are the first-ever i attempt to administer the off-label potent P2Y12 inhibitor ticagrelor as a part of dual antiplatelet therapy in patients with AF and ACS and ii evaluation of the reduced dose of ticagrelor in the setting of ACS The three most innovative aspects are i new treatment regimen with a reduced ticagrelor dose in ACS setting ii possibility to introduce the polypill containing ticagrelor and dabigatran to the Polish market and iii potential manufacture of the polypill containing various doses of ticagrelor and dabigatran depending on the patients individual ischaemic and bleeding risk If successful the proposed study will answer the burning clinical question about the optimal treatment strategy in patients with AF and ACS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-004887-24 | EUDRACT_NUMBER | None | None |