DOAC vs Warfarin as Blood Thinners After Heart Surgery (DANCE Trial)
Recruiting in Palo Alto (17 mi)
+6 other locations
Overseen ByEmilie Belley-Cote, MD, MSc
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Population Health Research Institute
Must be taking:Anticoagulants
Disqualifiers: Mechanical valve, Renal failure, Liver disease, others
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?The DANCE Trial is a multi-centre, randomized controlled trial comparing the safety of direct oral anticoagulants (DOAC) versus vitamin K antagonists (VKA) in the early period (30 days) after cardiac surgery in patients with atrial fibrillation requiring oral anticoagulation.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, since the trial involves comparing different blood thinners, you may need to switch to the study medication.
What data supports the effectiveness of DOACs as blood thinners after heart surgery?
Research shows that DOACs, like apixaban and rivaroxaban, are safer and more effective than warfarin for preventing strokes in patients with atrial fibrillation, with a lower risk of serious bleeding. This suggests they could be a good option for blood thinning after heart surgery.
12345Are DOACs and Warfarin safe for use after heart surgery?
Research suggests that direct oral anticoagulants (DOACs) like apixaban and rivaroxaban are generally safe and may be safer than warfarin, but they should be used with caution in people with kidney or liver issues. Unlike warfarin, DOACs do not require regular blood tests to monitor their effect, but they lack specific antidotes for reversing their action in case of severe bleeding.
12567How do DOACs differ from warfarin as blood thinners after heart surgery?
DOACs (Direct Oral Anticoagulants) like apixaban and rivaroxaban are easier to manage than warfarin because they don't require regular blood tests to monitor their effect. They also have a lower risk of causing bleeding in the brain, making them a safer option for some patients.
12348Eligibility Criteria
This trial is for adults over 18 who've had open heart surgery within the last 10 days and need blood thinners due to atrial fibrillation. It's not for those with severe kidney or liver disease, ongoing bleeding issues, mechanical heart valves, or women who are pregnant or could become pregnant.Inclusion Criteria
I have atrial fibrillation and need blood thinners.
I am 18 years old or older.
Exclusion Criteria
My kidneys are not working well (creatinine clearance <30 ml/min).
I have been diagnosed with triple-positive antiphospholipid syndrome.
I do not have severe liver disease.
I have had heart surgery, including a device implant or heart transplant.
I cannot take certain blood thinners due to health reasons.
I have a condition that causes ongoing bleeding or easy bruising.
I am pregnant, breastfeeding, or able to become pregnant.
Participant Groups
The DANCE Trial compares new blood thinners (DOAC) with traditional ones (VKA) right after cardiac surgery in patients with atrial fibrillation. Participants will be randomly assigned to one of these treatments to test safety over a period of 30 days.
2Treatment groups
Active Control
Placebo Group
Group I: Direct Oral Anticoagulation (DOAC)Active Control1 Intervention
Patients in the intervention group will receive a DOAC at doses recommended for the indication, adjusted for their renal function is required. The choice of DOAC will be at the discretion of the treating physician.
Group II: Vitamin K AntagonistPlacebo Group1 Intervention
Patients in the control group will receive VKA once daily; the individual dose will be titrated to achieve a guideline-recommended INR range.
DOAC is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
🇪🇺 Approved in European Union as DOACs for:
- Atrial fibrillation
- Deep vein thrombosis
- Pulmonary embolism
- Venous thromboembolism
🇺🇸 Approved in United States as DOACs for:
- Atrial fibrillation
- Deep vein thrombosis
- Pulmonary embolism
- Venous thromboembolism
- Stroke prevention
🇨🇦 Approved in Canada as DOACs for:
- Atrial fibrillation
- Deep vein thrombosis
- Pulmonary embolism
- Venous thromboembolism
🇯🇵 Approved in Japan as DOACs for:
- Atrial fibrillation
- Deep vein thrombosis
- Pulmonary embolism
- Venous thromboembolism
🇨🇳 Approved in China as DOACs for:
- Atrial fibrillation
- Deep vein thrombosis
- Pulmonary embolism
- Venous thromboembolism
🇨🇭 Approved in Switzerland as DOACs for:
- Atrial fibrillation
- Deep vein thrombosis
- Pulmonary embolism
- Venous thromboembolism
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Montreal Heart InstituteMontréal, Canada
Sunnybrook HospitalToronto, Canada
Toronto General HospitalToronto, Canada
IUCPQ-ULavalQuebec City, Canada
More Trial Locations
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Who is running the clinical trial?
Population Health Research InstituteLead Sponsor
Hamilton Health Sciences CorporationCollaborator
References
Safety of apixaban and rivaroxaban compared to warfarin after cardiac surgery. [2023]Direct oral anticoagulants (DOACs) are frequently prescribed for the management of atrial fibrillation and venous thrombosis. There is a lack of published data on the utilization of DOACs in individuals who have undergone recent cardiac surgery. The purpose of this study was to evaluate the safety and efficacy of apixaban and rivaroxaban compared to warfarin in patients postcardiac surgery.
Management of dental extraction in patients undergoing anticoagulant oral direct treatment: a pilot study. [2022]The main goal of this study was to compare the incidence of postoperative bleeding events after dental extractions between patients treated with direct oral anticoagulants (DOACs) and those treated with vitamin K antagonists (VKAs) without withdrawal of oral anticoagulant therapy (OAT). Our second objective was to evaluate the risk factors affecting postoperative hemorrhage after tooth extraction in patients taking DOACs.
[Stroke prevention with direct oral anticoagulants in patients with non-valvular atrial fibrillation]. [2015]The development of the direct oral anticoagulants (DOACs) represents one of the major breakthroughs in modern medicine over the last decade. Compared to vitamin K antagonists, all DOACs (dabigatran as a thrombin-Inhibitor, rivaroxaban, apixaban and edoxaban as factor Xa inhibitors) are much easier to handle due to their pharmacological properties. All DOACS are more efficacious and safer as vitamin K antagonists as demonstrated in the pivotal studies in more than 71,000 patients. Particularly the much lower risk of intracerebral bleeding complications is the reason why the DOACs should be preferred over vitamin K antagonists in patients with non-valvular atrial fibrillation.
Perioperative interruption of direct oral anticoagulants and vitamin K antagonists in patients with atrial fibrillation: A comparative analysis. [2023]There is a paucity of studies comparing postoperative thromboembolic and major bleeding complications following perioperative interruption of the direct oral anticoagulants (DOACs) and vitamin K antagonists (VKAs).
Perioperative Management of Direct Oral Anticoagulants (DOACs): A Systemic Review. [2020]Direct oral anticoagulants (DOACs) are in wide use among patients requiring both short- and long-term anticoagulation, mainly due to their ease of use and the lack of monitoring requirements. With growing use of DOACs, it is imperative that physicians be able to manage patients on these medications, especially in the perioperative period. We aim to provide guidance on the management of DOACs in the perioperative period. In this review, we performed an extensive literature search summarizing the management of patients on direct-acting anticoagulants in the perioperative period. A total of four direct-acting oral anticoagulants were considered appropriate for inclusion in this review. The drugs were dabigatran etexilate mesylate (Pradaxa), rivaroxaban (Xarelto), apixaban (Eliquis), and edoxaban (Savaysa). Management of patients on DOACs in the perioperative period involves an assessment of thromboembolic event risk while off anticoagulation compared to the relative risk of bleeding if such drug is continued. DOACs may not need to be discontinued in minor surgeries or procedures, and in major surgeries, they may be discontinued hours prior depending on drug pharmacokinetics and renal function of the patients.
[New oral anticoagulants (NOAC) in nephrology]. [2017]The new or direct oral anticoagulants [new oral anticoagulants (NOAC) or direct oral anticoagulants (DOAC)] were launched in the Italian market in 2013. Although these compounds share common pharmacological indications with vitamin K antagonists (warfarin or acenocumarol), they have different mechanisms of action, do not require a constant anticoagulant monitoring but are more efficacious and safer than vitamin K antagonists. The use of these molecules (Dabigatran, Apixaban, Rivaroxaban, Betrixaban, Edoxaban) is constantly rising in daily practice. However, while available data suggest that NOAC/DOAC use is safe, dosage should be adjusted based on renal or liver function. It should be acknowledged that commonly available blood tests [Prothrombin Time (PT) and partial thromboplastin time (PTT)] are not indicated to monitor the anticoagulant activity of these compounds. With the exception of dabigatran, we currently lack of an antidote to reverse the anticoagulant effect of NOAC/DOAC. We herein review available evidence on NOAC/DOAC pharmacokinetic, risk factors for bleeding, interventions to reverse the anticoagulant activity in case of hemorrhages or need of urgent surgery and/or NOAC/DOAC overdose or side effects.
Direct-acting oral anticoagulants: pharmacology, indications, management, and future perspectives. [2022]In recent years, several direct-acting oral anticoagulants (DOAC) have become available for use in Europe and other regions in indications related to prophylaxis and treatment of venous and arterial thromboembolism. They include the oral direct thrombin inhibitor dabigatran etexilate (Pradaxa, Boehringer Ingelheim) and the oral direct FXa inhibitors rivaroxaban (Xarelto, Bayer HealthCare), apixaban (Eliquis, Bristol-Myers Squibb), and edoxaban (Lixiana/Savaysa, Daiichi-Sankyo). The new compounds have a predictable dose response and few drug-drug interactions (unlike vitamin k antagonists), and they do not require parenteral administration (unlike heparins). However, they accumulate in patients with renal impairment, lack widely available monitoring tests for measuring its anticoagulant activity, and no specific antidotes for neutralization in case of overdose and/or severe bleeding are currently available. In this review, we describe the pharmacology of the DOAC, the efficacy, and safety data from pivotal studies that support their currently approved indications and discuss the postmarketing experience available. We also summarize practical recommendations to ensure an appropriate use of the DOAC according to existing data. Finally, we discuss relevant ongoing studies and future perspectives.
Bleeding Outcomes After Dental Extraction in Patients Under Direct-Acting Oral Anticoagulants vs. Vitamin K Antagonists: A Systematic Review and Meta-Analysis. [2021]Background: The current systematic review aimed to compare bleeding outcomes in dental extraction patients receiving uninterrupted Direct-acting oral anticoagulant (DOAC) or Vitamin K antagonists (VKAs) for various systemic diseases. Methods: PubMed, Embase, ScienceDirect, CENTRAL, and Google Scholar databases were searched for randomized controlled trials, controlled clinical trials, prospective and retrospective cohort studies, and case control studies, conducted on adult patients undergoing dental extraction under uninterrupted DOAC or VKAs therapy and reporting bleeding outcomes. The search was conducted up to March 31, 2021. We pooled data to calculate risk ratios (RR) with 95% confidence intervals (CI) in a random-effects model. Results: Eight studies comparing 539 patients on DOAC therapy and 574 patients on VKAs were included. Meta-analysis indicated a statistically significant lower bleeding risk in patients under DOAC therapy (RR 0.68 95% CI 0.49, 0.95 I2 = 0%). However, on sensitivity analysis, the results were statistically non-significant after exclusion of any of the included studies. On pooled analysis of limited number of studies, we found no statistically significant difference in the risk of bleeding between apixaban (RR 0.85 95% CI 0.45, 1.60 I2 = 0%), rivaroxaban (RR 0.95 95% CI 0.36, 2.48 I2 = 45%), dabigatran (RR 0.49 95% CI 0.19, 1.28 I2 = 5%), edoxaban (RR 0.41 95% CI 0.13, 1.27 I2 = 0%) and VKAs. Conclusion: The results of the first review comparing bleeding outcomes after dental extraction in patients on uninterrupted DOAC or VKA therapy indicates that patients on DOAC may have a reduced risk of hemorrhage. Current evidence is of very low-quality and should be interpreted with caution. Data on individual DOAC is scarce and at this point, the difference in the risk of bleeding between these drugs cannot be elucidated. Further studies with a large sample size shall supplement our conclusion.