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Dual Antithrombotic Therapy with Dabigatran and Ticagrelor in Patients with Acute Coronary Syndrome and Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention (ADONIS-PCI)
EU CTIS ID: 2024-515056-20-00
What this study is testing
To compare the safety and efficacy of two types of treatment: dual antithrombotic therapy with reduced dose of ticagrelor plus standard-of-care dabigatran (study group) and triple therapy with clopidogrel plus aspirin plus dabigatran (control group) in patients with AF and ACS, treated with PCI. The primary objective of this study is to test the hypothesis that dual antithrombotic therapy, including reduced dose ticagrelor, is non-inferior regarding bleeding risk and ischaemic protection compared to the standard triple therapy in patients with AF and after ACS, treated with PCI.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Male and female patients aged 18-99 years
- 2. Patients with new-onset or pre-existing non-valvular AF that have been receiving at least two doses of dabigatran before randomization or were treatment naïve prior to PCI. AF may be paroxysmal, persistent or permanent, but must not be secondary to a reversible disorder such as MI, pulmonary embolism, recent surgery, pericarditis or thyrotoxicosis unless long-term treatment with an OAC is anticipated.
- 3. Patients presenting with ACS that had undergone a successful PCI (either drug-eluting stent (DES) implantation or plain old balloon angioplasty (POBA)) within the previous 120 hours (in case of the multistage PCI during primary hospitalization the time should be counted from the last stage). ACS may be ST-elevation myocardial infarction (STEMI), non-STEMI (NSTEMI), or unstable angina (UA).
- 4. The patient must be able to give informed consent in accordance with ICH GCP guidelines and local legislation and/or regulations.
You likely can't join if
- Mechanical or biological heart valve prosthesis
- Gastrointestinal bleeding within 1 month prior to screening unless, in the opinion of the Investigator, the cause has been permanently eliminated (e.g., by surgery)
- Major bleeding episode (reduction in the haemoglobin level of at least 2 g/dL, transfusion of at least two units of blood, or symptomatic bleeding in a critical area or organ), including life- threatening bleeding episode (symptomatic intracranial bleeding, bleeding with a decrease in the haemoglobin level of at least 5 g/dL or bleeding requiring transfusion of at least 4 units of blood or inotropic agents or necessitating surgery) within 1 month prior to screening
- Stroke within 1 month prior to screening
- Major surgery within 1 month prior to screening
- Malignancy or radiation therapy within 6 months prior to screening unless, in the opinion of the Investigator, the estimated life expectancy is greater than 36 months
See the full eligibility criteria
Who can join
- 1. Male and female patients aged 18-99 years
- 2. Patients with new-onset or pre-existing non-valvular AF that have been receiving at least two doses of dabigatran before randomization or were treatment naïve prior to PCI. AF may be paroxysmal, persistent or permanent, but must not be secondary to a reversible disorder such as MI, pulmonary embolism, recent surgery, pericarditis or thyrotoxicosis unless long-term treatment with an OAC is anticipated.
- 3. Patients presenting with ACS that had undergone a successful PCI (either drug-eluting stent (DES) implantation or plain old balloon angioplasty (POBA)) within the previous 120 hours (in case of the multistage PCI during primary hospitalization the time should be counted from the last stage). ACS may be ST-elevation myocardial infarction (STEMI), non-STEMI (NSTEMI), or unstable angina (UA).
- 4. The patient must be able to give informed consent in accordance with ICH GCP guidelines and local legislation and/or regulations.
What rules you out
- Mechanical or biological heart valve prosthesis
- Gastrointestinal bleeding within 1 month prior to screening unless, in the opinion of the Investigator, the cause has been permanently eliminated (e.g., by surgery)
- Major bleeding episode (reduction in the haemoglobin level of at least 2 g/dL, transfusion of at least two units of blood, or symptomatic bleeding in a critical area or organ), including life- threatening bleeding episode (symptomatic intracranial bleeding, bleeding with a decrease in the haemoglobin level of at least 5 g/dL or bleeding requiring transfusion of at least 4 units of blood or inotropic agents or necessitating surgery) within 1 month prior to screening
- Stroke within 1 month prior to screening
- Major surgery within 1 month prior to screening
- Malignancy or radiation therapy within 6 months prior to screening unless, in the opinion of the Investigator, the estimated life expectancy is greater than 36 months
- History of intraocular, spinal, retroperitoneal, or traumatic intra-articular bleeding unless the causative factor has been permanently eliminated or repaired
- Haemorrhagic disorder or bleeding diathesis (e.g. von Willebrand disease, haemophilia A or B or other hereditary bleeding disorder, history of spontaneous intra-articular bleeding, history of prolonged bleeding after surgery/intervention)
- Past an organ transplant or patient on the waiting list for organ transplant
- Need for continued treatment with systemic ketoconazole, itraconazole, posaconazole, cyclosporine, tacrolimus, dronedarone, rifampicin, phenytoin, carbamazepine, St. John’s Wort or any cytotoxic/myelosuppressive therapy
- Need for continued treatment with non-steroidal anti-inflammatory drugs (NSAIDs)
- PCI with bare-metal stent implantation
- Pre-menopausal women (last menstruation ≤1 year prior to screening) who: o Are pregnant or breastfeeding or o Are not surgically sterile or o Are of childbearing potential and not practicing two acceptable methods of birth control, or do not plan to continue practicing an acceptable method of birth control throughout the trial. Acceptable methods of birth control are oral or parenteral (patch, injection, implant) hormonal contraception, which has been used continuously for at least one month prior to the first dose of study medication, intrauterine device or intrauterine system, double-barrier method of contraception (condom and occlusive cap or condom and spermicidal agent), male sterilization and complete sexual abstinence (if acceptable by local authorities). Periodic abstinence is not an acceptable method of contraception
- Known allergy to dabigatran, ticagrelor, clopidogrel, aspirin
- Contraindications, in the Investigator’s opinion to dabigatran, ticagrelor, clopidogrel, or aspirin
- Participation in another trial with an investigational drug or device within the past 30 days preceding the screening visit (patients participating in an observational study only will not be excluded)
- Patients who are not willing or able to comply with the protocol requirements or considered unreliable by the Investigator concerning the requirements for follow-up during the study and/or compliance with study drug administration, who have a life expectancy less than the expected duration of the trial due to concomitant disease, or who have any condition which in the opinion of the Investigator, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse).
- Unsuccessful PCI (>30% residual stenosis of the target lesion)
- Cardiogenic shock during current hospitalization
- Adverse bleeding or ischaemic event during current hospitalization
- Anaemia (haemoglobin <10 g/dL) or thrombocytopenia (platelet count <100 x109/L) at screening
- Severe renal impairment (creatinine clearance <30mL/min (estimated CrCl calculated by Cockcroft-Gault equation) at screening
- Active liver disease at screening defined as persistently elevated alanine aminotransferase (ALT) or aspartate transaminase (AST) levels >3 times the upper limit of normal (ULN)
- Use of fibrinolytic agents within 24 hours of screening
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.