New drug cocktail aims to cut bleeding and heart attacks in atrial fibrillation patients
NCT ID NCT03331484
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a combination of two drugs, rivaroxaban and ticagrelor, in 40 patients with atrial fibrillation who had a stent placed. The goal was to see if this combo causes less bleeding and prevents heart attacks or strokes better than current treatments. Patients took the drugs for one year, and researchers tracked bleeding events and heart-related outcomes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Rivaroxaban and Ticagrelor
- What this could lead to
- If successful, this could point toward a safer, more effective drug combination for managing heart disease in patients with atrial fibrillation after stent placement.
- What could go wrong
- This is a small, non-randomized study with only 40 participants, so results may not apply broadly. Bleeding risks remain a concern with these potent drugs.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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40 people
The number who actually took part.
- Started
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Nov 2018
- Finished
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Jul 2023
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patient has undergone a PCI with stent placement, plus 2. Documented non-valvular atrial fibrillation (AF)\* within 1 year before screening, OR \>1 year before screening if patient had been receiving oral anticoagulation (OAC)therapy for the atrial fibrillation for 3 months immediately before the index PCI. * AF is defined by its presence on an electrocardiogram (ECG), Holter monitor, or any device that provides a rhythm strip documenting paroxysmal, persistent or, permanent atrial fibrillation. Atrial flutter can be included as "AF equivalent". The stroke risk in patients with atrial flutter is not much different from that in AF. Furthermore, many patients diagnosed with atrial flutter subsequently develop AF. Hence, current guidelines recommend that OAC should be used in patients with atrial flutter similar to that in patients with AF. Non-valvular AF is defined as the absence of moderate to severe mitral stenosis or the presence of a mechanical valve as per 2016 ESC guidelines. Exclusion Criteria: 1. Age \<18 years old 2. Any condition that contraindicates anticoagulant therapy or would confer an unacceptable risk of bleeding, such as, but not limited to: i. active internal bleeding, ii. bleeding at a non-compressible site, iii. bleeding diathesis within 30 days of PCI, iv. baseline platelet count \<90,000/μL, v. history of intracranial hemorrhage, vi. clinically significant gastrointestinal bleeding within 12 months of PCI, vii. baseline INR \> 1.5 in patients not prescribed VKA, suggesting underlying coagulation disorder. 3. History of stroke 4. Cardiogenic shock at the time of screening 5. Ventricular arrhythmias refractory to treatment at the time of screening 6. Calculated CrCl \<30 mL/min at the time of screening 7. Known significant liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis), or liver function test (LFT) abnormalities at screening: alanine transaminase (ALT) \>5 times the upper limit of normal or ALT \>3 times the upper limit of normal plus total bilirubin \>2 times the upper limit of normal 8. Hemoglobin level \<90 g/dL at screening 9. Any severe condition that would limit life expectancy to less than 12 months 10. Major surgery, biopsy of a parenchymal organ, or serious trauma within the past 30 days 11. Incomplete staged PCI procedure (once completion of the staged PCI has occurred, the final PCI may become the index event) 12. CABG planned 13. Transient AF caused by a reversible disorder (e.g. thyrotoxicosis, pulmonary embolism, recent surgery) 14. Any condition other than non-valvular AF requiring long-term anticoagulation with VKAs such as moderate to severe mitral valve stenosis, mechanical heart valves, deep vein thrombosis, pulmonary embolism, or left ventricular thrombus 15. Known allergies, hypersensitivity, or intolerance to rivaroxaban or ticagrelor 16. Pregnant or planning to become pregnant while enrolled in this study, or unwilling to employ an investigator-approved method of birth control 17. Participation in a study with another investigational device or drug \< four weeks 18. Is receiving systemic treatment with strong inhibitors of both cytochrome P450 (CYP) 3A4 and p-glycoprotein (P-gp; eg, the azole-antimycotic ketoconazole and the HIV-protease inhibitor ritonavir). Treatment with fluconazole is allowed. 19. CHADS-VASC \<1
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7, Canada
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Other studies related to the condition(s) this trial covers.
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