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Trial record 43 of 56 for:    "Lung Disease" | "Dalteparin"

Efficacy and Safety of Half Dose Alteplase Added to Heparine, in Patients With Moderate Pulmonary Embolism (MONALYSE)

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ClinicalTrials.gov Identifier: NCT02604238
Recruitment Status : Not yet recruiting
First Posted : November 13, 2015
Last Update Posted : November 16, 2015
Sponsor:
Information provided by (Responsible Party):
Azienda U.S.L. 1 di Massa e Carrara

Brief Summary:

The primary aim of this study is to evaluate whether mid dose (safe dose) of Alteplase in addition to standard treatment with heparin (LMWH) in patients with pulmonary embolism (PE) at intermediate risk, it is effective to reduce:

  • right ventricular dysfunction
  • pulmonary hypertension 24 hours and 7 days after the treatment
  • PE recurrence to 7days and 30 days after the treatment without increasing the incidence of bleeding intra-extracranial

Condition or disease Intervention/treatment Phase
Pulmonary Embolism Drug: Alteplase Phase 3

Detailed Description:

The guidelines of the European Society of Cardiology (ESC2014) confirm the indication for pharmacological revascularization with thrombolysis only to cases of pulmonary embolism at high risk and thus hemodynamically unstable (class of recommendation I, level of evidence B), reserving the surgical or interventional procedures to cases where thrombolysis has failed or is contraindicated, while it remains controversial the role of thrombolysis in patients with pulmonary embolism at intermediate risk; the current state, in EP intermediate risk, the standard treatment involves the administration of low molecular weight heparin (LMWH), or fondaparinux (for 5-10 days followed by anticoagulation therapy with vitamin K antagonists) or alternatively the new anticoagulants oral (NAO). Although the results of the study PEITHO, recently published, confirm the indication for thrombolytic therapy for primary reperfusion in patients with embolism pulmonary high risk and provide element of reflection about the incidence of intracranial hemorrhage major, recent studies suggest that the thrombolysis with tPA to reduced dose (about half the dose that used in standard thrombolysis) in addition to anticoagulants (low molecular weight heparin) may reduce pulmonary hypertension (systolic artery pulmonary pressure> 40 mmHg) and the incidence of recurrent PE. In this protocol, based on the study MOPETT and pharmacokinetic data available, it is used a "safe dose" (safe dose reduced) of alteplase which provides a intravenous (iv) bolus loading dose of 10 mg in 1 min, followed by intravenous infusion 40 mg within two hours (for patients weighing <50 kg loading dose iv bolus of 0.5 mg in 1 min, followed by iv infusion of 40 mg within two hours).

After treatment with alteplase, the heparin therapy will be resumed when aPTT values are less than twice the upper limit of normal; the infusion will be adjusted to maintain aPTT between 50-70 seconds (1.5 to 2.5 times the reference value), and for safety reasons are excluded patients> 65 -70 years (increased risk of bleeding complications related age and comorbidities).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Thrombolytic Therapy With Half Dose Alteplase, Added to Standard Anticoagulation Therapy With Heparine, in Patients With Moderate Pulmonary Embolism: a Prospective, Randomized, Open Label,Controlled Trial
Study Start Date : March 2016
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Alteplase

Arm Intervention/treatment
Experimental: Group A
Administered a "safe dose" of Alteplase. All patients are treated with low molecular weight heparin ( LMWH ) according to the Guidelines ESC2014 heparin in addition it is administered a "safe dose" of Alteplase.
Drug: Alteplase
Enoxaparin (1mg) 100UI aXa/kg/sc [LMWH], 15 -30 minutes prior to administration of intravenous (iv) bolus loading dose of 10 mg in 1 min, followed by iv infusion of 40 mg within two hours (for patients weighing <50 kg, a loading dose of bolus of 0.5 mg in 1 min, followed by iv infusion of 40 mg in two hours); the infusion will be adjusted to maintain the value of aPTT between 50-70 seconds (1.5 to 2.5 times the reference value).
Other Name: tPA-tissue Plasminigen Activator

No Intervention: Group B
All patients are treated with low molecular weight heparin ( LMWH ) according to the Guidelines ESC2014 heparin. It not added any treatment.



Primary Outcome Measures :
  1. Pulmonary hypertension reduction (systolic pulmonary pressure greater or equal to 30 mm Hg) [ Time Frame: 24 hour ]
    Pulmonary hypertension reduction documented on echocardiography


Secondary Outcome Measures :
  1. Incidence of recurrent pulmonary embolism fatal or non fatal [ Time Frame: 7 days ]
    Incidence of recurrent pulmonary embolism fatal or non fatal

  2. Incidence of hemodynamic shock [ Time Frame: 24 hour and 30 days ]
    Incidence of hemodynamic shock [defined as: need for cardiopulmonary resuscitation, or SBP <90 mmHg for a period ≥15 min or reduction SBP ≥40 mm Hg for SBP ≥15 min, with evidence of systemic hypoperfusion (cold extremities, diuresis <30 mL / h, mental confusion), or need for infusion of amines to maintain adequate organ perfusion and SBP> 90 mm Hg

  3. Incidence of hospital death from all causes [ Time Frame: 30days ]
    Incidence of hospital death from all causes


Other Outcome Measures:
  1. Bleeding extracranial minor and major [ Time Frame: 24 hour and 30 days ]
    Bleeding extracranial minor and major



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. pulmonary embolism at intermediate risk as defined by the Guidelines ESC2014[ documented pulmonary CT angiography]
  2. pulmonary hypertension (systolic pulmonary pressure greater or equal to 40 mm Hg) [documented echocardiogram presence of thrombotic material in the right-sided]
  3. disfunction Ventricular right confirmed by echocardiogram or TC chest:

    • dilation of the right sections (> 30 mm in parasternal or relationship right ventricle/left ventricle > 1)
    • paradoxical movement of the interventricular septum
    • TAPSE reduced (Tricuspid Annular Plane Systolic Excursion)
    • tricuspid regurgitation with gradient VD/AD> 30 mmHg, in the absence of right ventricular hypertrophy, McConnell sign (apical segment of the free wall of the right ventricle normalKinetic or hyperkinetic than a hypokinesia or akinesia of the remaining parts of the right ventricular wall),
  4. myocardial damage confirmed with:

    • Troponin I or T positive
    • higt value of the biomarkers of myocardial damage : BNP or NTproBNP
  5. informed consent

Exclusion Criteria:

  1. age <18 years and> 65 years
  2. HASBLED score ≥ 3 (23)
  3. intracranial tumors
  4. ischemic stroke within 2 months
  5. surgery neurological within 1 month and surgery within 10 days
  6. trauma within 15 days
  7. hypotension to hospitalization (systemic blood pressure <90 mmHg)
  8. uncontrolled hypertension (SBP> 180mmHg and PAD> 110mmHg)
  9. clotting disorders
  10. thrombocytopenia (<100.000)
  11. platelet counts below 100 × 109 /L severe thrombocytopenia (platelet count <50.000 ptl / mm3)
  12. liver failure
  13. kidney failure
  14. gastrointestinal bleeding within 10 days
  15. pregnancy or childbirth within 30 days
  16. contraindications to the use of thrombolytics
  17. contraindications to the use of low molecular weight heparin (enoxaparin)
  18. anticoagulation therapy started more than 8 hours
  19. COPD
  20. endocarditis
  21. severe obesity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02604238


Contacts
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Contact: Alberto Conti, MD 3601095575 aaaconti@hotmail.com
Contact: Lorella Magnani, PharmD 0585498087 lorella.magnani@usl1.toscana.it

Sponsors and Collaborators
Azienda U.S.L. 1 di Massa e Carrara
Investigators
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Principal Investigator: Alberto Conti, MD Azienda USL1 di Massa e Carrara

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Responsible Party: Azienda U.S.L. 1 di Massa e Carrara
ClinicalTrials.gov Identifier: NCT02604238     History of Changes
Other Study ID Numbers: Azienda USL1 Massa e Carrara
First Posted: November 13, 2015    Key Record Dates
Last Update Posted: November 16, 2015
Last Verified: November 2015
Keywords provided by Azienda U.S.L. 1 di Massa e Carrara:
Pulmonary Embolism at intermediate risk
Additional relevant MeSH terms:
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Lung Diseases
Pulmonary Embolism
Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Respiratory Tract Diseases
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action