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

• Status: Unknown status
• Trial end date: 2021-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda U.S.L. 1 di Massa e Carrara
• Treatments: Dalteparin; Heparin, Low-Molecular-Weight; Tissue Plasminogen Activator

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