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

NCT05172115 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2021-12-29

No results posted yet for this study

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.

Conditions

  • Pulmonary Embolism
  • Pulmonary Thromboembolisms
  • Embolism, Pulmonary
  • Right Ventricular Dysfunction

Interventions

PROCEDURE

Conventional catheter-directed thrombolysis (CDT) with recombinant tissue plasminogen activator (rtPA)

Conventional catheter-directed thrombolysis with fixed-dose of 24 mg tissue plasminogen activator infusion over 24 hours

DRUG

Enoxaparin

Subcutaneous enoxaparin twice-daily (1mg/kg)

Sponsors & Collaborators

  • Rajaie Cardiovascular Medical and Research Center

    lead OTHER

Principal Investigators

  • Parham Sadeghipour, M.D · Rajaie Cardiovascular Medical and Research Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-22
Primary Completion
2020-02-02
Completion
2020-05-02

Countries

  • Iran

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05172115 on ClinicalTrials.gov