Low Molecular Weight Heparin for 72 Hours Followed by Dabigatran for Acute Intermediate-Risk Pulmonary Embolism.

Pulmonary Embolism Clinical Trial

— PEITHO-2  

Official title:

Safety and Efficacy of Low Molecular Weight Heparin for 72 Hours Followed by Dabigatran for the Treatment of Acute Intermediate-Risk Pulmonary Embolism

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02596555
• Other study ID #: PEITHO-2
• Status: Terminated
• Phase: Phase 4
• Start date: January 2016
• Est. completion date: February 2020

Study information

• Verified date: February 2020
• Source: Johannes Gutenberg University Mainz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This prospective, multicenter, multinational, phase IV, interventional single-armed (management) trial will focus on the safety, efficacy and cost-effectiveness of a new oral anticoagulant in the treatment of patients with acute intermediate-risk PE based on validated imaging (echocardiographic or CT angiographic) and laboratory biomarker (circulating levels of cardiac troponins and natriuretic peptides) parameters and their combinations.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 400
• Est. completion date: February 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age =18 years

2. Objectively confirmed diagnosis of acute PE by multidetector CT angiography, ventilation/perfusion lung scan, or selective invasive pulmonary angiography, according to established diagnostic criteria, with or without symptomatic deep vein thrombosis

3. Absence of hemodynamic collapse, or decompensation, at presentation; Hemodynamic collapse or decompensation

4. Intermediate-risk category of PE severity indicated by a positive (score =1) simplified pulmonary embolism severity index (sPESI), in combination with the presence of at least one of the following criteria at presentation:

• At least one sign of RV pressure overload/dysfunction on CT angiography or echocardiography

• Signs of myocardial injury as indicated by elevated troponin levels

• Signs of (RV) failure as indicated by NT-proBNP levels >600 pg/ml at baseline.

5. Ability of the subject to understand the character and individual consequences of the clinical trial; signed and dated informed consent of the subject available before the start of any specific trial procedures

Exclusion Criteria:

1. Pregnancy (a negative serum or urine pregnancy test should be available for women of child-bearing potential before study inclusion) or lactation

2. Women of childbearing potential who do not practice a medically accepted highly effective contraception during the trial and one month beyond

3. History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product

4. Participation in another clinical trial during the present clinical trial or within the last three months

5. Medical or psychological condition that would not permit completion of the trial or signing of informed consent

6. Use of a fibrinolytic agent, surgical thrombectomy, interventional (catheter-directed) thrombus aspiration or lysis, or use of a cava filter to treat the index episode of PE

7. Treatment with any therapeutically dosed anticoagulant for more than 48 hours prior to enrolment

8. Need for long-term treatment with a low molecular weight heparin, vitamin K antagonists or NOAC, for an indication other than the index PE episode, or for antiplatelet agents except acetylsalicylic acid at a dosage =100 mg/day;

9. Active bleeding or known significant bleeding risk (e.g., gastrointestinal ulcer, malignant neoplasms, injuries or recent surgeries of the brain, spinal cord or eyes, recent intracranial bleedings, known or suspected esophagus varices, aneurysms or intraspinal or intracranial vascular abnormalities)

10. Artificial heart valves requiring treatment with an anticoagulant

11. Renal insufficiency with estimated creatinine clearance <30 ml/min/1.73m2

12. Chronic liver disease with aminotransferase levels two times or more above the local upper limit of normal range

13. Concomitant administration of strong inhibitors of P-glycoprotein like ketoconazole, cyclosporin, itraconazole or dronedarone

14. Unwillingness or inability to adhere to treatment or to the follow-up visits

15. Life expectancy less than 6 months

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

Drug:
• Dabigatran
Low molecular weight heparin for 72 hours followed by 6 months of dabigatran

Locations

Country	Name	City	State
Germany	Center for Thrombosis and Hemostasis, University Medical Center Mainz	Mainz

Sponsors (2)

Lead Sponsor	Collaborator
Prof. Stavros Konstantinides, MD	European Georges Pompidou Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of symptomatic venous thromboembolism (VTE) or pulmonary embolism (PE) related death (yes/no)		6 months
Secondary	Recovery of right ventricle (RV) function		6±1 days or upon discharge (whichever comes first), 6 months
Secondary	Temporal pattern of changes in NT-proBNP (N-terminal prohormone of brain natriuretic peptide) levels		6±1 days or upon discharge (whichever comes first), 6 months
Secondary	Death from any cause		30 days
Secondary	Pulmonary embolism (PE) related death, or PE-related or hemodynamic collapse or decompensation		30 days
Secondary	Overall duration of hospital stay		6 months
Secondary	Major bleeding		6 months
Secondary	Clinically relevant bleeding		6 months
Secondary	Serious adverse events (SAE)		72 hours, 30 days, 6 months