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

NCT02604238 | Withdrawn Phase 3 DMC

• 1 other identifier: Azienda USL1 Massa e Carrara
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Pulmonary Embolism

Keywords

Pulmonary Embolism at intermediate risk

Outcome Measures

Primary Outcomes (1)

• Pulmonary hypertension reduction (systolic pulmonary pressure greater or equal to 30 mm Hg)

  Pulmonary hypertension reduction documented on echocardiography

  24 hour

Secondary Outcomes (3)

• Incidence of recurrent pulmonary embolism fatal or non fatal

  7 days

• Incidence of hemodynamic shock

  24 hour and 30 days

• Incidence of hospital death from all causes

  30days

Other Outcomes (1)

• Bleeding extracranial minor and major

  24 hour and 30 days

Study Arms (2)

Group A

EXPERIMENTAL

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

Group B

NO INTERVENTION

All patients are treated with low molecular weight heparin ( LMWH ) according to the Guidelines ESC2014 heparin. It not added any treatment.

Interventions

Alteplase DRUG

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).

Also known as: tPA-tissue Plasminigen Activator

Group A

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• pulmonary embolism at intermediate risk as defined by the Guidelines ESC2014\[ documented pulmonary CT angiography\]
• pulmonary hypertension (systolic pulmonary pressure greater or equal to 40 mm Hg) \[documented echocardiogram presence of thrombotic material in the right-sided\]
• 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),
• myocardial damage confirmed with:
• Troponin I or T positive
• higt value of the biomarkers of myocardial damage : BNP or NTproBNP
• informed consent

You may not qualify if:

• age \<18 years and\> 65 years
• HASBLED score ≥ 3 (23)
• intracranial tumors
• ischemic stroke within 2 months
• surgery neurological within 1 month and surgery within 10 days
• trauma within 15 days
• hypotension to hospitalization (systemic blood pressure \<90 mmHg)
• uncontrolled hypertension (SBP\> 180mmHg and PAD\> 110mmHg)
• clotting disorders
• thrombocytopenia (\<100.000)
• platelet counts below 100 × 109 /L severe thrombocytopenia (platelet count \<50.000 ptl / mm3)
• liver failure
• kidney failure
• gastrointestinal bleeding within 10 days
• pregnancy or childbirth within 30 days

Sponsors & Collaborators

• Azienda U.S.L. 1 di Massa e Carrara: lead

MeSH Terms

Conditions

Pulmonary Embolism

Interventions

Tissue Plasminogen Activator

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors

Study Officials

• Alberto Conti, MD

  Azienda USL1 di Massa e Carrara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2015
• First Posted: November 13, 2015
• Study Start: March 1, 2016
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: February 8, 2024

Record last verified: 2018-06