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New treatment option for Atrial Fibrillation
Official title Dual Antithrombotic Therapy With Dabigatran and Ticagrelor in Patients With ACS and Non-valvular AF Undergoing PCI
ClinicalTrials.gov ID: NCT04695106
What this study is testing
What is Ticagrelor?
Ticagrelor is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for atrial fibrillation.
Also referred to as Brilique.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male and female patients aged ≥18 years'
- Patients with new-onset or pre-existing non-valvular AF that have been receiving oral anticoagulant treatment with dabigatran for at least 48 hours...
- Patients presenting with ACS that had undergone a successful PCI with drug-eluting stent (DES) implantation or plain old balloon angioplasty within...
- 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;
- PCI with bare-metal stent insertion;
- 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,
See the full eligibility criteria
- Male and female patients aged ≥18 years'
- Patients with new-onset or pre-existing non-valvular AF that have been receiving oral anticoagulant treatment with dabigatran for at least 48 hours or were treatment naïve prior to PCI. AF may be paroxysmal, persistent...
- Patients presenting with ACS that had undergone a successful PCI with drug-eluting stent (DES) implantation or plain old balloon angioplasty within the previous 120 hours. ACS may be ST-elevation myocardial infarction...
- The patient must be able to give informed consent in accordance with ICH GCP guidelines and local legislation and/or regulations.
- Mechanical or biological heart valve prosthesis;
- PCI with bare-metal stent insertion;
- 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) \>3-fold upper limit of normal (ULN)
- Use of fibrinolytic agents within 24 hours of screening;
- 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 hemoglobin 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...
- 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;
- Hemorrhagic disorder or bleeding diathesis (e.g. von Willebrand disease, hemophilia A or B or other hereditary bleeding disorder, history of spontaneous intra-articular bleeding, history of prolonged bleeding after...
- 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);
- Pre-menopausal women (last menstruation ≤1 year prior to screening) who: sre pregnant or breastfeeding or are not surgically sterile or are of childbearing potential and not practicing two acceptable methods of birth...
- Known allergy to dabigatran, ticagrelor, clopidogrel, aspirin, or to the excipients used for the tables of the drugs;
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Gdansk, Pomeranian Voivodeship, Poland
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gdansk, Pomeranian Voivodeship, Poland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.