Pulmonary Embolism Clinical Trial
— CANARYOfficial title:
Catheter-Directed Thrombolysis Versus ANticoagulation Monotherapy in Patients With Acute Intermediate-High Risk PulmonarY Embolism: The CANARY Randomized Clinical Trial
Verified date | December 2021 |
Source | Rajaie Cardiovascular Medical and Research Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In an open-label parallel groups blinded-endpoint randomized clinical trial, the investigators aim to assess the safety and efficacy of conventional catheter-directed thrombolysis (CDT) vs anticoagulation monotherapy on outcomes of patients with acute intermediate-high risk pulmonary embolism. The investigators hypothesize that CDT will have a superior efficacy and safety compared with anticoagulation-only therapy regarding the proportion of patients with a right ventricle to left ventricle (RV/LV) ratio > 0.9 at a 3-month follow-up by an imaging core laboratory, major bleeding, severe thrombocytopenia, or vascular access complication.
Status | Terminated |
Enrollment | 94 |
Est. completion date | May 2, 2020 |
Est. primary completion date | February 2, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Patients =18 years 2. Confirmed acute pulmonary emboli by computed tomography pulmonary angiography (CTPA) 3. Symptom onset =14 day 4. Elevated N-terminal-proB-type natriuretic peptide and cardiac troponin 5. Right ventricle/left ventricle ratio >0.9 in transthoracic echocardiography 6. Less than 48 hours of anticoagulation therapy 7. Willingness for participation in the study with signed and dated informed consent form Exclusion Criteria: 1. Pulmonary emboli detected by modalities other than CTPA 2. Segmental PE 3. High risk (massive) 4. Severe renal dysfunction(creatinine clearance [CrCl] below 30 mL/min) 5. Terminal illness Surgery within 2 weeks 6. Platelet count <50.000 /µL 7. Pre and post catheter directed thrombolysis echocardiography exam not possible 8. Contraindication to thrombolytic therapy 9. Concomitant right heart thrombi 10. Allergic reaction to study medications 11. Lack or withdrawal of informed consent |
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | Rajaie Cardiovascular Medical and Research Center | Tehran |
Lead Sponsor | Collaborator |
---|---|
Rajaie Cardiovascular Medical and Research Center |
Iran, Islamic Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | A composite of all-cause death or the primary outcome | Composite patients who died or patients with a RV/LV ratio >0.9 at a assessed by an imaging core laboratory 3-month follow-up | Within 3-month Study period | |
Other | PE-related mortality. | Autopsy-confirmed PE with no more likely cause of death or objectively confirmed PE before death in the absence of another more likely cause of death | Within 3-month Study period | |
Other | Hospital length of stay | The total days of the initial hospitalization | Within 3-month Study period | |
Other | Six-minute walk test (6MWt) at three-month follow up | The functional capacity of the patient | Within 3-month Study period | |
Primary | The proportion of patients with a RV/LV ratio >0.9 | Proportion of patients with a RV/LV ratio >0.9 at a assessed by an imaging core laboratory 3-month follow-up | At 3 months from randomization | |
Secondary | The proportion of patients with an RV/LV ratio >0.9 | A composite of the proportion of patients with a RV/LV ratio >0.9 at a assessed by an imaging core laboratory 72 hours follow-up | At 72 hours from randomization | |
Secondary | The proportion of patients with Unrecovered RV | The PEITHO definition for RV recovery was employed, as follows: 1) RV size (at the mid-cavity level In apical 4-chamber view) <35 mm, 2) pulmonary artery pressure <35 mm Hg, 3) an RV/LV ratio <0.9, and 4) the normalization of RV free wall motion. The fulfillment of all the criteria, some criteria, and none of the criteria was defined as complete, partial, and no recovery, respectively. | At 3 months from randomization | |
Secondary | All-cause mortality | Survival status of the patient (being alive or dead) at the end of 3 months follow up | Within 3-month Study period | |
Secondary | Major bleeding | According to the Bleeding Academic Research Consortium (BARC 3 or 5 bleeding) | Within 3-month Study period | |
Secondary | Severe thrombocytopenia | Platelet count <20.000/µL | Within 3-month Study period | |
Secondary | Vascular access complication | Major vascular access complication | Within 3-month Study period |
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