Venous thromboembolism (VTE), clinically presenting as deep vein thrombosis (DVT) or acute pulmonary embolism (PE), is the third most frequent acute cardiovascular syndrome after myocardial infarction and stroke. The research unit of the Department of Angiology has the goal of establishing novel pharmacological and interventional strategies for the management of acute venous thromboembolism. Our research includes multinational randomized clinical trials, prospective management studies, epidemiological analyses, and observational practice-based studies.
Professor Nils Kucher and PD Dr. Stefano Barco serve as experts and panellists for international guidelines and consensus documents on the treatment of venous thromboembolism.
The following investigator-initiated trials studies have been launched at the Department of Angiology and are sponsored by the University of Zurich:
- OVID (NCT04400799) phase III randomized controlled trial: Enoxaparin for primary thromboprophylaxis in ambulatory patients with COVID-19. The SNF-funded OVID trial will show whether prophylactic-dose enoxaparin improves survival and reduces unplanned hospitalizations in ambulatory patients aged 50 or older diagnosed with COVID-19. A total of 1.000 patients will be recruited at 8 centers in Switzerland and in Germany. A predefined interim analysis is planned after approximately 50% of the final study population. Sponsor: University of Zurich. Status: interim analysis.
- RETHRO (2021-00579): Novel catheter-based REperfusion strategies for the treatment of acute deep vein THROmbosis or pulmonary embolism. This study focuses on a few specific aspects related to the use of novel reperfusion therapies for acute deep vein thrombosis and pulmonary embolism, including pharmacological local reperfusion, novel catheter-directed reperfusion strategies, and novel catheter-directed mechanical strategies. Sponsor: University of Zurich. Status: ongoing.
The Department of Angiology is involved in the design and conduction of the following multinational trials and observational studies:
- ASTER (NCT05171049): A Study Comparing Abelacimab to Apixaban in the Treatment of Cancer-associated VTE. A multicenter, randomized, open-label, blinded endpoint evaluation, phase 3 study comparing the effect of abelacimab relative to apixaban on venous thromboembolism (VTE) recurrence and bleeding in patients with cancer-associated VTE. Sponsor: Anthos Therapeutics. Status: approval pending.
- MAGNOLIA (2021-0003085-12): A multicenter, randomized, open-label, blinded endpoint evaluation, phase 3 study comparing the effect of abelacimab relative to dalteparin on venous thromboembolism (VTE) recurrence and bleeding in patients with gastrointestinal (GI)/genitourinary (GU) cancer associated VTE. The purpose of this phase 3 study is to assess whether monthly treatment with abelacimab is non-inferior to daily administration of dalteparin in preventing VTE recurrence but is superior in the rate of bleeding in patients with GI/GU cancer and recently diagnosed VTE. This study will support worldwide registration of abelacimab for the treatment of cancer-associated VTE. Sponsor: Anthos Therapeutics. Status: approval pending.
- ADJUST-DVT (NCT02384135): Age-adjusted D-dimer Cutoff Levels to Rule Out Deep Vein Thrombosis, a Prospective Outcome Study. Prospective validation of an age-adjusted D-dimer cut-off to rule out deep vein thrombosis (DVT). Sponsor: Geneva University Hospital. Status: recruiting.
- HI-PEITHO (NCT04790370) phase III trial: Ultrasound-facilitated, Catheter-directed, Thrombolysis in Intermediate-high Risk Pulmonary Embolism phase III trial. Patients will be randomized 1:1 to receive either blood thinners (anticoagulation) or blood thinners (anticoagulation) in combination with a device called the EkoSonicTM Endovascular device to dissolve pulmonary blood clots. Patients will be followed for 12 months and have assessments while in the hospital as well as at 7 days, 30 days, 6 months and 12 months after treatment. The study will try to find out if a treatment with EkoSonicTM Endovascular plus anticoagulation is better than anticoagulation alone at reducing the risk of death and other serious problems. Sponsor: Boston Scientific. Status: approval in Switzerland pending; study ongoing in the US and Europe (participation also as Steering Committee members).
- FLASH (NCT03761173): FlowTriever All-Comer Registry for Patient Safety and Hemodynamics. FLASH has the goal of evaluating the safety and effectiveness of the FlowTriever System for use in the removal of emboli from the pulmonary arteries in the treatment of acute pulmonary embolism (PE). The use of the device will be assessed in a real-world population, with eligibility criteria that closely approximate its use in clinical practice. At the Department of Angiology in Zurich only high-risk (hemodynamically unstable) patients with acute PE will be enrolled. Sponsor: Inari medical. Status: ongoing.
- API-CAT (NCT03692065) phase III trial: API-CAT STUDY for APIxaban Cancer Associated Thrombosis. The main objective of API-CAT is to determine whether a low-dose regimen of apixaban (2.5 mg bid) is non inferior to a full-dose regimen of apixaban (5 mg bid) for the prevention of recurrent venous thromboembolism (VTE) in patients with active cancer who have completed at least 6 months of anticoagulant therapy for treating a documented index event of proximal deep venous thrombosis (DVT) (symptomatic or incidental) or pulmonary embolism (symptomatic or incidental). Sponsor: Assistance Publique – Hôpitaux de Paris. Status: site initiation visit.
- PEITHO-3 (NCT04430569) phase III trial: Pulmonary Embolism International THrOmbolysis Study-3. A reduced dose of thrombolytic treatment for patients with intermediate high-risk acute pulmonary embolism. Sponsor: Boston Scientific. Status: ongoing (involvement only as Steering Committee and Adjudication Committee member).
- COBRRA (NCT03266783) phase III trial: Comparison of Bleeding Risk Between Rivaroxaban and Apixaban for the Treatment of Acute Venous Thromboembolism. Apixaban and rivaroxaban have been compared to standard therapy for treatment of acute symptomatic venous thromboembolism (VTE) in randomized controlled trials (RCTs), and are both approved by Health Canada. No safety or efficacy data is available from direct head-to-head comparison of these two anticoagulants. Lawsuits in the United States over bleeding events, patient perceptions, and concerns with medication adherence are additional factors highlighting the importance of a comparison trial. This multi-center, pragmatic, prospective, randomized, open-label, blinded end-point (PROBE) trial aims to compare the safety of apixaban and rivaroxaban for the treatment of VTE. Sponsor: Ottawa Hospital Research Institute. Status: ongoing (involvement only as Adjudication Committee member).
- KNOCOUT (NCT03426124): An International Pulmonary Embolism Registry Using EKOS. Retrospective and prospective international EKoSoNic® registry Of the treatment and Clinical OUTcomes of patients with pulmonary Embolism. Sponsor: Boston Scientific. Status: study closed, publication pending.
- Garfield-VTE (NCT02155491): Global Anticoagulant Registry in the Field of VTE. Global Anticoagulant Registry in the FIELD observing treatment and out-comes in patients with acute symptomatic Venous Thromboembolic Events (VTE) in the real world. Sponsor: Thrombosis Research Institute. Status: recruitment completed.
- REDUCE prospective cohort study: Management of recurrent venous thromboembolism during anticoagulant treatment in cancer patients. This study will observe adult cancer patients with symptomatic or incidental recurrent VTE while receiving LMWH or DOACs for acute VTE. The objective is to evaluate clinical outcomes during guideline-recommended LMWH dose escalation for recurrent VTE during LMWH or DOAC treatment for cancer-associated thrombosis. Sponsor: Amsterdam University Medical Center. Status: approval pending.
- ETNA-VTE-Europe (NCT02943993): Non-Interventional Study on Edoxaban Treatment in routiNe clinical prActice in Patients with Venous ThromboEmbolism in Europe. This study aims to gather further insight into efficacy (i.e. symptomatic recurrent VTE) and safety (i.e. bleeding events, liver adverse events, all-cause mortality and other drug related adverse events) of extended treatment with the anticoagulant edoxaban in an unselected patient population in routine clinical practice. Sponsor: Daiichi Sankyo Europe GmbH. Status: recruitment completed.