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Pulmonary EmbolismPhase 4PEITHO-2NCT02596555

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

A Phase 4 study testing Dabigatran in people with Pulmonary Embolism, run by Prof. Stavros Konstantinides, MD at 1 site in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pulmonary Embolism
What is being tested?
Dabigatran
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
1 siteGermany
Study dates
Jan 2016to Feb 2020
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years
  • 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
  • Absence of hemodynamic collapse, or decompensation, at presentation; Hemodynamic collapse or decompensation
  • 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.
  • 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

Who cannot join

  • Pregnancy (a negative serum or urine pregnancy test should be available for women of child-bearing potential before study inclusion) or lactation
  • Women of childbearing potential who do not practice a medically accepted highly effective contraception during the trial and one month beyond
  • 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
  • Participation in another clinical trial during the present clinical trial or within the last three months
  • Medical or psychological condition that would not permit completion of the trial or signing of informed consent
  • 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
Show all 15Show fewer
  • Treatment with any therapeutically dosed anticoagulant for more than 48 hours prior to enrolment
  • 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;
  • 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)
  • Artificial heart valves requiring treatment with an anticoagulant
  • Renal insufficiency with estimated creatinine clearance <30 ml/min/1.73m2
  • Chronic liver disease with aminotransferase levels two times or more above the local upper limit of normal range
  • Concomitant administration of strong inhibitors of P-glycoprotein like ketoconazole, cyclosporin, itraconazole or dronedarone
  • Unwillingness or inability to adhere to treatment or to the follow-up visits
  • Life expectancy less than 6 months

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Center for Thrombosis and Hemostasis, University Medical Center Mainz

    Mainz, 55131

Other trials in Germany

About this study

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

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.

Being tested
Dabigatran
Medical subject headings
Pulmonary Embolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DabigatranDrug

    Also called Pradaxa

    Low molecular weight heparin for 72 hours followed by 6 months of dabigatran

Study groups in NCT02596555
Study groupRoleWhat they receive
Dabigatran treatmentExperimentalLow molecular weight heparin for 72 hours followed by 6 months of dabigatran
Receives: Drug: Dabigatran

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of symptomatic venous thromboembolism (VTE) or pulmonary embolism (PE) related death (yes/no)

    Measured: 6 months

Secondary outcomes (8)

  1. Recovery of right ventricle (RV) function

    Measured: 6±1 days or upon discharge (whichever comes first), 6 months

  2. Temporal pattern of changes in NT-proBNP (N-terminal prohormone of brain natriuretic peptide) levels

    Measured: 6±1 days or upon discharge (whichever comes first), 6 months

  3. Death from any cause

    Measured: 30 days

  4. Pulmonary embolism (PE) related death, or PE-related or hemodynamic collapse or decompensation

    Measured: 30 days

  5. Overall duration of hospital stay

    Measured: 6 months

  6. Major bleeding

    Measured: 6 months

  7. Clinically relevant bleeding

    Measured: 6 months

  8. Serious adverse events (SAE)

    Measured: 72 hours, 30 days, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2015 (estimated)
  2. Study startJan 2016
  3. Primary completionFeb 2020
  4. Study completionFeb 2020

Why it stopped: 1. Interim results suggested a reduction of sample size. 2. Anticipated length of enrolment period with resulting funding issues to pose a threat to the study.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02596555
Sponsor's protocol ID
PEITHO-2
Acronym
PEITHO-2
Status last verified
Feb 2020
First submitted
3 Nov 2015
Last updated
17 Feb 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • Klok FA, Toenges G, Mavromanoli AC, Barco S, Ageno W, Bouvaist H, Brodmann M, Cuccia C, Couturaud F, Dellas C, Dimopoulos K, Duerschmied D, Empen K, Faggiano P, Ferrari E, Galie N, Galvani M, Ghuysen A, Giannakoulas G, Huisman MV, Jimenez D, Kozak M, Lang IM, Lankeit M, Meneveau N, Munzel T, Palazzini M, Petris AO, Piovaccari G, Salvi A, Schellong S, Schmidt KH, Verschuren F, Schmidtmann I, Meyer G, Konstantinides SV; PEITHO-2 investigators. Early switch to oral anticoagulation in patients with acute intermediate-risk pulmonary embolism (PEITHO-2): a multinational, multicentre, single-arm, phase 4 trial. Lancet Haematol. 2021 Sep;8(9):e627-e636. doi: 10.1016/S2352-3026(21)00203-9. Epub 2021 Aug 4.

    PubMed 34363769

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dabigatran in people with Pulmonary Embolism, run by Prof. Stavros Konstantinides, MD at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: 1. Interim results suggested a reduction of sample size. 2. Anticipated length of enrolment period with resulting funding issues to pose a threat to the study.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of symptomatic venous thromboembolism (VTE) or pulmonary embolism (PE) related death (yes/no) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02596555, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.

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