Anticoagulation vs Thrombectomy for Pulmonary Embolism
Recruiting in Palo Alto (17 mi)
+18 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Penumbra Inc.
Must not be taking: Thrombolytics, Glycoprotein IIb/IIIa
Disqualifiers: Hemodynamic instability, ECMO, CTEPH, others
No Placebo Group
Approved in 6 Jurisdictions
Trial Summary
What is the purpose of this trial?
The primary objective of this trial is to evaluate the safety and efficacy of treatment with anticoagulation alone versus anticoagulation and mechanical aspiration thrombectomy with the Indigo Aspiration System for the treatment of intermediate-high risk acute pulmonary embolism (PE).
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on thrombolytic agents or certain other medications, you may not be eligible to participate.
What data supports the effectiveness of anticoagulants for treating pulmonary embolism?
Research shows that direct oral anticoagulants (DOACs) like apixaban, rivaroxaban, and dabigatran are effective for treating pulmonary embolism and preventing its recurrence. They are as effective as traditional treatments like warfarin, with some studies indicating a lower risk of major bleeding.12345
Is anticoagulation generally safe for humans?
Direct oral anticoagulants (DOACs) like apixaban, rivaroxaban, and dabigatran are generally considered safe for treating blood clots, but they can accumulate in people with kidney problems and lack specific antidotes for overdose. They have fewer drug interactions and don't require injections, but monitoring their effects can be challenging.13678
How do anticoagulant drugs differ from other treatments for pulmonary embolism?
Anticoagulant drugs, especially direct oral anticoagulants (DOACs) like rivaroxaban, apixaban, and dabigatran, offer a more convenient alternative to traditional treatments by eliminating the need for regular blood monitoring and dietary restrictions associated with warfarin. They work by directly inhibiting specific factors in the blood clotting process, which can reduce the risk of bleeding compared to older therapies.125910
Eligibility Criteria
Adults aged 18-80 with recent acute pulmonary embolism confirmed by imaging, showing specific heart strain and elevated heart markers. Candidates must have suitable veins for the procedure and give informed consent. Excluded are those with active cancer, severe blood pressure issues, certain allergies or bleeding disorders, recent major surgery, pregnancy, or other investigational trial participation.Inclusion Criteria
My veins are suitable for a specific lung artery procedure.
I have a confirmed pulmonary embolism shown by a CT scan.
I have had signs of a pulmonary embolism for 14 days or less.
See 3 more
Exclusion Criteria
I have severe heart or blood pressure problems needing intense support.
Imaging evidence or other evidence that suggests, in the opinion of the Investigator, that catheter-based intervention is not appropriate for the patient
Current participation in another investigational drug or device trial that may confound the results of this trial. Studies requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational studies
See 16 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either anticoagulation alone or anticoagulation plus mechanical aspiration thrombectomy with the Indigo Aspiration System
48 hours
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of functional outcomes and quality of life
90 days
Treatment Details
Interventions
- Anticoagulation (Anticoagulant)
- Mechanical Aspiration Thrombectomy (Thrombectomy Device)
Trial OverviewThe study compares two treatments for serious lung clots: standard blood thinners alone versus blood thinners plus a device that physically removes clots (Indigo Aspiration System). The goal is to see which method is safer and more effective.
Participant Groups
2Treatment groups
Active Control
Group I: Anticoagulation (AC)Active Control1 Intervention
Subjects will have their pulmonary embolism treated with anticoagulants alone. There will be no procedure for this group.
Group II: IndigoActive Control1 Intervention
Subjects will have their pulmonary embolism treated with anticoagulants and mechanical aspiration thrombectomy with the Indigo® Aspiration System.
Anticoagulation is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
🇪🇺 Approved in European Union as Anticoagulants for:
- Pulmonary Embolism
- Deep Vein Thrombosis
- Atrial Fibrillation
- Venous Thromboembolism
🇺🇸 Approved in United States as Anticoagulants for:
- Pulmonary Embolism
- Deep Vein Thrombosis
- Atrial Fibrillation
- Venous Thromboembolism
🇨🇦 Approved in Canada as Anticoagulants for:
- Pulmonary Embolism
- Deep Vein Thrombosis
- Atrial Fibrillation
- Venous Thromboembolism
🇯🇵 Approved in Japan as Anticoagulants for:
- Pulmonary Embolism
- Deep Vein Thrombosis
- Atrial Fibrillation
- Venous Thromboembolism
🇨🇳 Approved in China as Anticoagulants for:
- Pulmonary Embolism
- Deep Vein Thrombosis
- Atrial Fibrillation
- Venous Thromboembolism
🇨🇭 Approved in Switzerland as Anticoagulants for:
- Pulmonary Embolism
- Deep Vein Thrombosis
- Atrial Fibrillation
- Venous Thromboembolism
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of MarylandBaltimore, MD
Kingwood Medical CenterKingwood, TX
Wellstar KennestoneMarietta, GA
The University of Arizona - BannerTucson, AZ
More Trial Locations
Loading ...
Who Is Running the Clinical Trial?
Penumbra Inc.Lead Sponsor
References
Differences between activities of coagulation factors after one month of therapy with different direct oral anticoagulant in pulmonary embolism patients. [2019]Direct oral anticoagulants (DOACs) are frequently used for the treatment of pulmonary embolism (PE), but both clinical and laboratory data comparing their efficacy and safety are conflicting. This study investigated and compared the impact of three DOACs (apixaban, rivaroxaban and dabigatran) on coagulation cascade in acute PE patients.
Acute pulmonary embolism: risk assessment, risk stratification and treatment options. [2019]Pulmonary embolism (PE) is a potentially life-threatening cardiovascular emergency with a high mortality rate. Rapid diagnosis and treatment are important in optimising clinical outcomes in patients with PE, and anticoagulants are the mainstay of treatment. Traditionally, anticoagulant therapy involves parenteral anticoagulants, overlapping with and followed by oral vitamin K antagonists. Direct oral anticoagulants (DOACs), including the factor Xa inhibitors rivaroxaban, apixaban and edoxaban, and the direct thrombin inhibitor dabigatran etexilate, have been developed to address limitations associated with traditional anticoagulant therapy. Apixaban, dabigatran and rivaroxaban have recently been approved for the treatment of acute deep vein thrombosis (DVT) and PE and prevention of recurrent DVT or PE. Edoxaban is approved in the United States but not currently in the European Union for the treatment of DVT and PE; approval of edoxaban in Europe is anticipated in the near future.
Early prescription of direct oral anticoagulant for the treatment of intermediate-high risk pulmonary embolism: a multi-center, observational cohort study. [2021]The safety and efficacy of direct oral anticoagulants (DOACs) in intermediate-high risk pulmonary embolism (PE) are unknown. The aims of the present study were to describe outcomes of patients receiving early apixaban or rivaroxaban prescription rather than the recommended delayed prescription strategy.
Direct Oral Anticoagulants and Their Use in Treatment and Secondary Prevention of Acute Symptomatic Venous Thromboembolism. [2016]Direct oral anticoagulants (DOACs) have been compared with standard therapy in large phase III studies to assess their safety and efficacy in the treatment of deep vein thrombosis and/or pulmonary embolism and in the secondary prevention of recurrent venous thromboembolism. Although the mean population age and the gross inclusion and exclusion criteria were similar across these studies, they differed in other aspects such as overall study design and acute treatment strategies. The 4 DOACs examined in phase III trials (apixaban, edoxaban, rivaroxaban, and dabigatran) showed noninferiority compared with standard therapy for the treatment of deep vein thrombosis and/or pulmonary embolism and for the prevention of recurrent venous thromboembolism. Furthermore, these DOACs exhibited a similar safety profile to standard therapy, with the risk of major bleeding significantly reduced in some of these studies. Rivaroxaban and apixaban were tested as a single-drug approach, whereas in the dabigatran and edoxaban studies, initial bridging with parenteral agents was employed. The purpose of this review is to compare the phase III studies of DOACs in this indication, to highlight the differences, and to discuss a series of clinically relevant issues, including the management of key patient subgroups (eg, fragile patients, those with cancer or renal impairment), extended treatment, use of comedications, heparin pretreatment versus a single-drug approach, and the bleeding profiles of the DOACs.
Frequency of Direct Oral Anticoagulants Usage in Acute Pulmonary Thromboembolism Treatment in Turkey (TUPEDO). [2022]Direct oral anticoagulants (DOACs) have been used in acute pulmonary thromboembolism as an alternative to warfarin due to drug interactions, narrow therapeutic range, and necessary close International Normalized Ratio (INR) monitoring. Phase 3 study results have reported that these drugs are at least as effective as warfarin and beneficial in terms of bleeding; however, studies that present up-to-date life data are necessary.
Safety of direct oral anticoagulants in patients with liver disease: a systematic review and meta-analysis. [2023]Direct oral anticoagulants (DOACs), such as apixaban, edoxaban, rivaroxaban, or dabigatran, are an effective treatment for atrial fibrillation (AF) and deep venous thromboembolism. We hope to evaluate the safety of DOACs versus warfarin/low molecular weight heparin (LMWH) in improving bleeding events in patients with different severity of the liver disease.
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.
Dabigatran, rivaroxaban and apixaban for extended venous thromboembolism treatment: network meta-analysis. [2015]Many new oral anticoagulants (NOACs; dabigatran, rivaroxaban, and apixaban) are currently available to treat thromboembolic disease. There are no head-to-head trials comparing these agents. To assess the efficacy and safety of NOACs for prevention of recurrent venous thromboembolism (VTE), we performed a network meta-analysis.
Comparison of rivaroxaban mono-therapy and standard-therapy adjusted by CYP2C9 and VKORC1 genotypes in symptomatic pulmonary embolism. [2017]Pulmonary embolism (PE) is a life-threatening manifestation of venous thromboembolism. Rivaroxaban is an oral anticoagulant, which directly inhibits Factor Xa. The objective of the current study was, in comparison to the standard-therapy method, to investigate the potential of rivaroxaban to improve the treatment of patients with PE, and to reduce hemorrhage in the standard-therapy group through adjusting the dose of warfarin by CYP2C9 and VKORC1 genotypes.
A cost comparison of warfarin vs enoxaparine or new oral anticoagulants used for the treatment of patients with pulmonary embolism. [2023]Recently, novel oral anticoagulants (rivaroxaban, dabigatran, apixaban) have been approved for pulmonary embolism (PE) treatment. Each anticoagulant used during initial and maintenance therapy has direct and indirect costs for healthcare systems. Demonstrating the costs of treatment with different anticoagulants in a specific patient group will be helpful for clinicians determining treatment strategies.