Clinical Investigators Group (CIG)

The CIG is a working group for Principal Investigators and interested trainees to discuss and troubleshoot ongoing CanVECTOR-led multicentre clinical studies and plan new studies. The group typically hold monthly teleconferences and meet at three face-to-face meetings a year.

Click below to view the newly funded, actively recruiting, active but completed recruiting, and published CIG studies.

New Funded Studies

02. EPCAT III

Principal Investigator: Sudeep Shivakumar

Funding: CIHR

Design: RCT evaluating extended VTE prophylaxis comparing rivaroxaban and aspirin to aspirin alone following total hip and knee arthroplasty

03. Muffin PTS

Principal Investigators: Jean-Philippe Galanaud, Susan Kahn

Funding: CIHR

Design: RCT evaluating venoactive medication vs placebo for reduction in PTS

 

04. PEITHO III

Principal Investigators: Kerstin de Wit

Co-Investigators:
Lana Castellucci and Marc Rodger (Ottawa)
Ali Mulla
Sudeep Shivakumar (Halifax)
Andrew Hirsch and Susan Kahn (Montreal)

Funding: CanVECTOR Pilot

Design: Prospective cohort study of patients on warfarin or DOAC for at least 3 months who require cessation of anticoagulation for a planned elective procedure.

05. Periop-3

Principal Investigator: Michael Kovacs

Design: Prospective observational cohort of patients on Warfarin or DOAC (Direct Oral Anticoagulant) for at least 3 months who require cessation of anticoagulation for a planned elective procedure.

09. RithMM

Principal Investigators: Martha Louzada

Funding: London Multiple Myeloma Support Group

Design: Pilot open-label RCT to compare the efficacy and safety of Rivaroxaban or ASA in preventing venous or arterial thromboembolic events in patients with myeloma on Len-Dex based therapy

For more information:NCT03428373 https://clinicaltrials.gov/

10. TILE Pilot study

Principal Investigators: Jean Philippe Galanaud, Susan Kahn;

Funding: LEO Pharma

Design: RCT comparing 3-weeks of tinzaparin then DOAC vs DOAC alone for prevention of PTS in high-risk symptomatic DVT patients (Iliac vein or common femoral vein).

Active Studies: Recruiting

21. ADJUST-DVT

Full Title Study: Age-adjusted D-dimer Cutoff Levels to Rule Out Deep Vein Thrombosis: a Prospective Outcome Study

Principal Investigators: Gregoire Le Gal, Marc Righini

Funding: HSF (Heart and Stroke Foundation of Canada)

Design: Prospective cohort to validate an age-adjusted D-dimer cut-off to rule out DVT (deep vein thrombosis)

For more information: NCT02384135 https://clinicaltrials.gov/

 

22. CATHETER 3

Full Study Title:  Central Venous Catheter (CVC) Associated Deep Vein Thrombosis (DVT) in Cancer Patients

Principal Investigators: Michael Kovacs

Funding: self-funded

Design: Cohort study of cancer patients with central line associated DVT (deep vein thrombosis) in the upper extremity treated with 1 week of LMWH (low-molecular-weight heparin) followed by Apixaban 5 mg bid x 3 months

For more information: NCT03100071 https://clinicaltrials.gov/

 

23. COBRRA

Full Study Title: Comparison of Bleeding Risk Between Rivaroxaban and Apixaban for the Treatment of Acute Venous Thromboembolism

Principal Investigator: Lana Castellucci

Funding: CIHR (Canadian Institutes of Health Research)

Design: Open-label RCT (randomized clinical trial) comparing bleeding risk with rivaroxaban versus apixaban for acute treatment of VTE (venous thromboembolism)

For more information: NCT03266783 https://clinicaltrials.gov/

24. LEaD

Full Study Title: Safely Ruling Out Deep Vein Thrombosis in Pregnancy With the LEFt Clinical Decision Rule and D-Dimer

Principal Investigator: Marc Rodger

Funding: CIHR (Canadian Institutes of Health Research)

Design: Prospective cohort study using the LEFt clinical decision rule and D-dimer for DVT (deep vein thrombosis) diagnosis in pregnant women who present with signs and symptoms of DVT (deep vein thrombosis)

For more information: NCT02507180 https://clinicaltrials.gov/

 

25. Pilot PARTUM

Principal Investigator: Leslie Skeith, Marc Rodger

Funding: CIHR, INVENT

Design: Pilot RCT assessing the feasibility of an RCT evaluating aspirin in postpartum women at risk of developing VTE 

26. PERIOP-01

Full Study Title: Extended Peri-operative Tinzaparin to Improve Disease-free Survival in Patients With Resectable Colorectal Cancer

Principal Investigators: Marc Carrier, Rebecca Auer

Funding: CIHR (Canadian Institutes of Health Research), LEO (Leo Pharma)

Design: Open-label RCT (randomized clinical trial) of extended peri-operative tinzaparin in patients with resectable colorectal cancer to improve cancer specific survival following surgical resection

For more information: NCT01455831 https://clinicaltrials.gov/

 

27. PROXY

Full Study Title: 

Principal Investigators: Sam Schulman

Funding: Octapharma

Design: Pilot prospective cohort study assessing the prothrombin complex concentrate for emergency surgery in patients on oral Xa-inhibitors

 

28. RIVASVT-100

Principal Investigators: Aurélien Delluc

Co-Investigators:
Mark Crowther (Hamilton)
Sébastien Miranda (Ottawa)
Alejandro Lazo-Langner (London)
Walter Agenda (Italy)

Funding: CanVECTOR Pilot

Design: Prospective pilot cohort study investigating treatment of portal, mesenteric, and splenic vein thrombosis with rivaroxaban.

29. REMAP-ATTACC

Full Study Title: Antithrombotic Therapy to Ameliorate Complications of COVID-19

Principal Investigator: Ryan Zarychanski

Patient Partners: N/A

Funding: CIHR (Canadian Institutes of Health Research)

Design: A prospective, open-label, randomized, multicentre, adaptive clinical trial

For more information: NCT04372589 https://clinicaltrials.gov/

 

 

30. TRIM-Line

Full Study Title: Thromboprophylaxis with Rivaroxaban in Patients with Malignancy and Central Venous Lines

Principal Investigators: Rick Ikesaka, Marc Carrier

Funding: CanVECTOR Pilot

Design: Pilot double-blind placebo-controlled RCT (randomized clinical trial) investigating primary thromboprophylaxis with rivaroxaban in patients with malignancy and central venous catheters.

For more information: NCT03506815 https://clinicaltrials.gov/

33. SSPE

Full Study Title: A Study to Evaluate the Safety of Withholding Anticoagulation in Patients With Subsegmental PE Who Have a Negative Serial Bilateral Lower Extremity Ultrasound

Principal Investigator: Marc Carrier

Funding: HSF (Heart and Stroke Foundation of Canada)

Design: Prospective management cohort study of patients with isolated SSPE (subsegmental pulmonary embolism), left untreated

For more information: NCT01455818 https://clinicaltrials.gov/

 

33. VVIRTUOSO

Full Study title: Venous Thrombosis Virtual Surveillance in COVID

Principal Investigators: Deborah Siegel

Funding: CIHR (Canadian Institutes of Health Research)

Design: Prospective multi-centre observational cohort study of 500 patients enrolled consecutively at 12 sites over 3 months

34. WAVe

Principal Investigators: Marc Carrier

Funding: Pfizer

Design: Prospective cohort study assessing the use of weight-adjusted dalteparin inpatients over 90 kg with acute cancer-associated venous thromboembolism.

For more information: NCT03297359 https://clinicaltrials.gov/

Active Studies: Recruitment Completed

60. BLEEDING RISK

Full Study Title: Predicting Bleeding Risk on Anticoagulant Therapy for Venous Thromboembolism

Principal Investigator: Phil Wells

Funding: HSF (Heart and Stroke Foundation of Canada)

Design: Cohort study of VTE (Venous Thromboembolism) patients on anticoagulants to derive a decision rule for bleeding

For more information: NCT00788736 https://clinicaltrials.gov/

Published Abstract: ISTH 2017 - Research and Practice in Thrombosis and Haemostasis: Bleed Risk 

 

61. COBRRA Pilot

Full Study Title: Comparison of Bleeding Risk Between Rivaroxaban and Apixaban

Principal Investigator: Lana Castellucci

Funding: CanVECTOR Pilot

Design: Open-label pilot RCT (randomized clinical trial) comparing bleeding risk with rivaroxaban versus apixaban

For more information: NCT02559856 https://clinicaltrials.gov/

62. COVET

Full Study Title: Comparison of Oral Anticoagulants for Extended VEnous Thromboembolism

Principal Investigators: Lana Castellucci, Thomas Ortel, David Garcia

Patient Partner: Ryan O'Connell

Funding: PCORI (Patient-Centered Outcomes Research Institute)

Design: Pragmatic open-label RCT (randomized clinical trial) comparing the safety and efficacy of rivaroxaban, apixaban and warfarin for the long-term treatment of unprovoked VTE (venous thromboembolism).

For more information: NCT03196349 https://clinicaltrials.gov/

63. DABI-PTS

Full Study Title: Prevalence of Post-Thrombotic Syndrome in Deep-Vein Thrombosis (DVT) Patients Treated With Dabigatran

Principal Investigators: Sam Schulman, Susan Kahn

Funding: BI (Boehringer Ingelheim Canada)

Design: Cohort of patients enrolled in RECOVER I and II to assess the prevalence of PTS (post-thrombotic syndrome) using the recently developed patient self-reported Villalta (PRV) Scale

For more information: NCT03050138 https://clinicaltrials.gov/

64. PAUSE

Full Study Title: Perioperative Anticoagulant Use for Surgery Evaluation Study

Principal Investigator: Jim Douketis

Funding: CIHR (Canadian Institutes of Health Research), HSF (Heart and Stroke Foundation of Canada)

Design: Prospective cohort study of patients with atrial fibrillation on new oral anticoagulants requiring interruption for elective surgery/procedure; looking to develop a safer perioperative protocol

For more information: NCT02228798 https://clinicaltrials.gov/

 

65. PERIOP 2

Full Study Title: A Safety and Effectiveness of LMWH vs Placebo Bridging Therapy for Patients on Long Term Warfarin Requiring Temporary Interruption of Warfarin

Principal Investigator: Michael Kovacs

Funding: CIHR (Canadian Institutes of Health Research), Pfizer

Design: Double-blind RCT (randomized clinical trial) of post-procedure bridging with LMWH (low-molecular-weight heparin) versus placebo for patients on long-term warfarin who require temporary interruption of warfarin

For more information: NCT00432796 https://clinicaltrials.gov/

 

66. PLATO-VTE

Full Study Title: Tumor-educated Platelets in Venous Thromboembolism

Principal Investigators: Noemie Kraaijpoel, Marc Carrier

Funding: CanVECTOR Pilot

Design: Pilot prospective cohort study assessing the diagnostic accuracy of platelet mRNA profiling for occult cancer in the setting of VTE (venous thromboembolism) -  (primary outcome of the pilot is the recruitment rate)

For more informationNCT02739867 https://clinicaltrials.gov/

67. PREDICTORS

Full Study Title: Clinical Predictors for Venous Thromboembolism in Patients With a History of Thrombosis

Principal Investigators: Gregoire Le Gal

Funding: HSF (Heart and Stroke Foundation of Canada)

Design: Prospective cohort of patients with a history of thrombosis and new symptoms of VTE (venous thromboembolism); evaluating the performance of current clinical decision rules with this population

For more information: NCT02297373 https://clinicaltrials.gov/

 

68. RASET

Full Study Title: Rivaroxaban Anticoagulation for Superficial Vein Thrombosis

Principal Investigator: Clive Kearon

Funding: Bayer

Design: Double-blind RCT (randomized clinical trial) of rivaroxaban versus placebo for treatment of superficial vein thrombosis

For more information: NCT02123524 https://clinicaltrials.gov/

69. SAVER Pilot

Full Study Title: StAtins for Venous Event Reduction in Patients With Venous Thromboembolism Pilot Study

Principal Investigator: Marc Rodger

Patient Partners: Rob Adriaanse, Ryan O'Connell

Funding: CIHR (Canadian Institutes of Health Research)

Design: Open-label pilot RCT (randomized clinical trial) of rosuvastatin to prevent recurrent VTE (venous thromboembolism) and reduce PTS (post-thrombotic syndrome) in patients with VTE (venous thromboembolism)

For more information: NCT02679664 https://clinicaltrials.gov/

70. STEP-CAT

Full Study Title: Reduction to Preventive Doses of Enoxaparin After 3 to 6 Months of Treatment With Blood Thinners for Cancer-associated Blood Clots

Principal Investigator: Vicky Tagalakis

Funding: Sanofi

Design: Pilot management cohort study involving cancer patients with DVT (deep vein thrombosis) or PE (pulmonary embolism); step down to prophylactic doses of enoxaparin after 3-6 months of full-dose treatment

For more information:NCT02752607 https://clinicaltrials.gov/

Published Studies

50. APPLE

Full Study Title: AntiPhospholipid Syndrome Low-molecular-weight Heparin Pregnancy Loss Evaluation: The Pilot Study

Principal Investigators: Leslie Skeith, Marc Rodger

Funding: CanVECTOR Pilot, LEO (Leo Pharma)

Design: Open-label pilot RCT of antepartum prophylaxis with LMWH and ASA versus ASA alone in women with confirmed antiphospholipid syndrome (APS) and a history of past pregnancy loss

Study Publication: https://www.thrombosisresearch.com/article/S0049-3848(20)30207-3/pdf

For more informationNCT03100123 https://clinicaltrials.gov/

51. AVERT

Full Study Title: Apixaban for the Prevention of Venous Thromboembolism in Cancer Patients

Principal Investigators: Marc Carrier, Phil Wells

Funding: CIHR (Canadian Institutes of Health Research), BMS (BMS Pfizer (Bristol-Myers Squibb Pfizer)

For more information: NCT02048865 https://clinicaltrials.gov/

Publicationhttps://www.nejm.org/doi/full/10.1056/NEJMoa1814468

52. Catheter 2

Full Study Title: Study in Cancer Patients With Central Line Associated Clots in the Upper Extremity Treated With Rivaroxaban

Principal Investigator: Michael J. Kovacs

Study Publicationhttp://www.sciencedirect.com/science/article/pii/S0049384817302578?via%3Dihub

54. EPCAT II

Full Study Title: Extended Venous Thromboembolism Prophylaxis Comparing Rivaroxaban to Aspirin Following Total Hip and Knee Arthroplasty

Principal Investigator: David Anderson

Funding: CIHR (Canadian Institutes of Health Research)

Design: Double-blind RCT (randomized clinical trial) of rivaroxaban vs. aspirin for total knee and total hip arthroplasty

For more information: NCT01720108 https://clinicaltrials.gov/

Study Publication: http://www.nejm.org/doi/full/10.1056/NEJMoa1712746

55. PAUSE

Full Study Title: Perioperative Anticoagulant Use for Surgery Evaluation Study

Principal Investigator: Jim Douketis

Funding: CIHR (Canadian Institutes of Health Research), HSF (Heart and Stroke Foundation of Canada)

Design: Prospective cohort study of patients with atrial fibrillation on new oral anticoagulants requiring interruption for elective surgery/procedure; looking to develop a safer perioperative protocol

For more information: NCT02228798 https://clinicaltrials.gov/

Study Publication: https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2740207

 

56. PEGeD

Full Study Title: D-dimer Testing Tailored to Clinical Pretest Probability in Suspected Pulmonary Embolism

Principal Investigators: Clive Kearon

Funding: Canadian Institutes of Health Research (CIHR)

Design: Prospective, multi-centre, cohort study that will assess a new diagnostic management strategy for suspected Pulmonary Embolism (inpatients and outpatients.

For more information: NCT02483442 https://clinicaltrials.gov/

Study Publication: https://www.nejm.org/doi/pdf/10.1056/NEJMoa1909159?articleTools=true

57. REVERSE II

Full Study Title: Clinical Decision Rule Validation Study to Predict Low Recurrent Risk in Patients With Unprovoked Venous Thromboembolism

Principal Investigator: Marc Rodger

Funding: Funded by a grant from the French Ministry of Health (PHRC 2009-08-05) and BioMerieux

Study Publicationhttp://www.bmj.com/content/356/bmj.j1065

58. RAPS

Full Study Title: Rivaroxaban for Antiphospholipid Antibody Syndrome

Principal Investigators: Mark Crowther, Kimberly Legault

Funding: HSF (Heart and Stroke Foundation of Canada), Bayer

Design: Pilot prospective management study of rivaroxaban for patients with antiphospholipid antibody syndrome

Study Publication:  https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-020-00594-1

59. TRIM-Line Pilot

Principal Investigators: Rick Ikesaka, Marc Carrier

Funding: CanVECTOR Pilot

Design: Pilot double-blind placebo-controlled RCT (randomized clinical trial) investigating primary thromboprophylaxis with rivaroxaban in patients with malignancy and central venous catheters.

Study Publicationhttps://academy.isth.org/isth/2020/milan/297236/rick.ikesaka.thromboprophylaxis.with.rivaroxaban.in.patients.with.malignancy.html

60. UPRATE

Full Study Title: Prothrombin Complex Concentrate for Major Bleeding on Factor Xa Inhibitors: A Prospective Cohort Study

Principal Investigator: Sam Schulman

Funding: Octapharma

Study Publication (Abstract): https://www.thieme-connect.de/DOI/DOI?10.1055/s-0038-1636541