TerminatedPhase 3

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

Stopped: Due to the COVID-19 pandemic

Iran94 participantsStarted 2018-12-22

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patients ≥18 years
✓. Confirmed acute pulmonary emboli by computed tomography pulmonary angiography (CTPA)
✓. Symptom onset ≤14 day
✓. Elevated N-terminal-proB-type natriuretic peptide and cardiac troponin
✓. Right ventricle/left ventricle ratio \>0.9 in transthoracic echocardiography
✓. Less than 48 hours of anticoagulation therapy
✓. Willingness for participation in the study with signed and dated informed consent form

Exclusion criteria

✕. Pulmonary emboli detected by modalities other than CTPA
✕. Segmental PE
✕. High risk (massive)
✕. Severe renal dysfunction(creatinine clearance \[CrCl\] below 30 mL/min)

What they're measuring

The proportion of patients with a RV/LV ratio >0.9

Timeframe: At 3 months from randomization

Trial details

NCT IDNCT05172115

SponsorRajaie Cardiovascular Medical and Research Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-02-02

View on ClinicalTrials.gov More Pulmonary Embolism trials