Catheter-Directed Thrombolysis Versus Anticoagulation Monotherapy in Intermediate-High Risk PE

• Status: Terminated
• Trial end date: 2020-05-02
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rajaie Cardiovascular Medical and Research Center
• Treatments: Dalteparin; Enoxaparin; Heparin; Heparin, Low-Molecular-Weight; Plasminogen; Tinzaparin; Tissue Plasminogen Activator

Criteria

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