Protocol summary
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Study aim
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To compare right venticular dysfunction, clinical deterioration, bleeding, mortality, functional class between catheter directed thrombolysis versus anticoagulation alone in patients with Intermediate- High Risk pulmonary emboli
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Design
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Randomized, parallel groups, with blinded outcome assessment controlled trial
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Settings and conduct
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The trial will be held in a hospital setting (Rajaie Cardiovascular Center and Tehran Heart Center) on patients with acute pulmonary emboli. Patients will be randomized via central web based method into intervention and control groups. Patients and physicians are not blinded. Echocardiographic indexes will be recorded on admission and 72 hours later. In follow up period, echocardiography exam and 6-minute walk test for functional class will be performed.
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Participants/Inclusion and exclusion criteria
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Inclusion:
Men and women ≥ 18 year-old, Acute pulmonary emboli must be confirmed with pulmonary CT angiography, Symptoms onset ≤ 14 days, Elevated pro b-type natriuretic peptide and cardiac troponin, Right ventricle/left ventricle ratio in pulmonary CT angiography >0.9
Exclusion:
Pulmonary emboli diagnosed with other modalities than pulmonary CT angiography, High risk (massive) pulmonary emboli, Severe renal dysfunction (creatinine clearance below 30 mL/min), Thrombolytic contraindication, Concomitant right heart thrombosis
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Intervention groups
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The intervention group will receive catheter directed thrombolysis. After femoral vein puncture, an infusion catheter will be inserted to the diseased pulmonary artery and thrombolytic will be started locally.
The control group will receive oral anticoagulation according to guideline
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Main outcome variables
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Primary outcome:
Right ventricular function; right ventricular size; in-hospital deterioration
Secondary outcome:
Mortality; functional class during follow up; Minor and Major Bleeding
General information
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Reason for update
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Adding the acronym, and the termination date
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Acronym
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CANARY
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IRCT registration information
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IRCT registration number:
IRCT20181022041406N1
Registration date:
2019-01-27, 1397/11/07
Registration timing:
registered_while_recruiting
Last update:
2021-12-10, 1400/09/19
Update count:
2
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Registration date
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2019-01-27, 1397/11/07
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-12-22, 1397/10/01
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Expected recruitment end date
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2021-12-22, 1400/10/01
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Actual recruitment start date
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2018-12-22, 1397/10/01
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Actual recruitment end date
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2020-02-02, 1398/11/13
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Trial completion date
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2020-05-02, 1399/02/13
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Scientific title
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Catheter directed thrombolysis versus anticoagulation only in patients with Intermediate-high risk pulmonary emboli-A randomized clinical trial
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Public title
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Thrombolysis via catheter in treatment of Pulmonary Emboli
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Men and women ≥ 18 year-old
Acute pulmonary emboli must be confirmed with pulmonary CT angiography
Symptoms onset ≤ 14 days
Elevated pro b-type natriuretic peptide and cardiac troponin
Right ventricle/left ventricle ratio in pulmonary CT angiography >0.9
simplified pulmonary embolism severity index score >=1
Less than 48 hours of anticoagulation therapy
Exclusion criteria:
Pulmonary emboli diagnosed with other modalities than pulmonary CT angiography
High risk (massive) pulmonary Emboli
Segmental pulmonary emboli
Patient with terminal illness
Surgery within 2 weeks
Severe renal dysfunction (creatinine clearance [CrCl] below 30 mL/min)
Platelet count <50.000
Thrombolytic contraindication
Concomitant right heart thrombosis
Pre and post catheter directed thrombolysis echocardiography exam not possible
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Age
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From 18 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
288
Actual sample size reached:
94
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In the present study, concealment will be central via the website: http://thcresearch.net. After entering the username and password by the investigator, the patient ID will be asked by the web-based program. Then by using the permuted block randomization method, each patient (individual) will be assigned to intervention or control group.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-11-14, 1397/08/23
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Ethics committee reference number
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IR.RHC.REC.1397.050
Health conditions studied
1
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Description of health condition studied
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Pulmonary emboli
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ICD-10 code
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I26
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ICD-10 code description
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Pulmonary embolism
Primary outcomes
1
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Description
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Right ventricular diameter/left ventricular diameter ratio
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Timepoint
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3-month after intervention
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Method of measurement
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Echocardiography
Secondary outcomes
1
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Description
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Mortality
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Timepoint
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During hospitalization and 3-months after intervention
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Method of measurement
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Questionnaire
2
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Description
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Minor bleeding
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Timepoint
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Duration of hospitalization
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Method of measurement
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Bleeding Academic Research Consortium scale
3
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Description
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Major bleeding
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Timepoint
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Duration of hospitalization
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Method of measurement
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Bleeding Academic Research Consortium scale
4
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Description
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Right ventricular diameter/left ventricular diameter ratio
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Timepoint
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72 hours after intervention
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Method of measurement
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Echocardiography
5
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Description
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Right ventricular recovery
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Timepoint
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3 months after intervention
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Method of measurement
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Echocardiography
Intervention groups
1
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Description
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Intervention group: The group will receive catheter directed thrombolysis. After femoral vein puncture, an infusion catheter will be inserted to the diseased pulmonary artery and thrombolytic will be started locally.
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Category
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Treatment - Drugs
2
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Description
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Control group: The group will receive oral anticoagulation according to guideline
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Rajaie Cardiovascular Medical and Research Center
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available