Reduced-Dose Versus Full-Dose Alteplase for High-Risk Pulmonary Embolism (REDSTEM)
14. září 2026 aktualizováno: Kristina Svennerholm, Sahlgrenska University Hospital
Reduced-Dose Versus Full-Dose Systemic Thrombolysis for High-Risk Pulmonary Embolism: A Multicentre, Randomised, Open-Label, Blinded-Endpoint Trial
High-risk pulmonary embolism is a life-threatening condition requiring immediate reperfusion therapy. Full-dose systemic thrombolysis is recommended as first-line treatment, but its use is limited by the risk of major bleeding, including intracranial hemorrhage. Reduced-dose systemic thrombolysis may reduce bleeding while maintaining clinical efficacy, but this strategy has not been adequately evaluated in patients with high-risk pulmonary embolism.
REDSTEM is an international, multicenter, randomized, adaptive, open-label, blinded-endpoint phase 4 trial comparing reduced-dose alteplase with standard full-dose alteplase in adults with acute high-risk pulmonary embolism. The trial will assess whether reduced-dose alteplase preserves early clinical efficacy while reducing severe clinically significant bleeding. Participants will be followed for up to 12 months.
Přehled studie
Postavení
Zatím nenabíráme
Podmínky
Intervence / Léčba
Detailní popis
Systemic thrombolysis is recommended as first-line reperfusion therapy for high-risk pulmonary embolism. However, bleeding complications limit its use in clinical practice and contribute to undertreatment of eligible patients. Existing evidence from small randomized trials, observational studies, and meta-analyses suggests that lower-dose thrombolysis may improve safety while maintaining efficacy, but previous studies have included mixed-risk pulmonary embolism populations and only a limited number of patients with high-risk pulmonary embolism.
REDSTEM was designed to evaluate whether a reduced-dose alteplase strategy can provide a more favorable balance between efficacy and safety compared with standard full-dose alteplase in patients with high-risk pulmonary embolism. The study uses randomized treatment allocation, blinded endpoint adjudication, independent safety monitoring, and an adaptive design allowing sample-size re-estimation if required.
The trial includes early clinical assessments during the acute phase and follow-up through 12 months to evaluate clinical outcomes, safety, functional recovery, quality of life, and health care resource utilization.
Typ studie
Intervenční
Zápis (Odhadovaný)
400
Fáze
- Fáze 4
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Kristina Svennerholm, MD PhD
- Telefonní číslo: +46313421000
- E-mail: kristina.svennerholm@vgregion.se
Studijní záloha kontaktů
- Jméno: Annika Odenstedt, Coordinator
- Telefonní číslo: +46313421000
- E-mail: annika.odenstedt@vgregion.se
Studijní místa
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Copenhagen, Dánsko
- Rigshospitalet
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Kontakt:
- Jesper Kjaergaard, MD, PhD
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Bergen, Norsko, 5021
- Haukeland University Hospital
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Kontakt:
- Lasse Melvear Gii, MD, PhD
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Drammen, Norsko, 3004
- Drammen Hospital
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Kontakt:
- Jonas Pivoriunas, MD, PhD
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Grålum, Norsko, 1714
- Ostfold Hisptal
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Kontakt:
- Hans Joakim Myklebust-Hansen, MD
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Lörenskog, Norsko, 1478
- Akershus University Hospital
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Kontakt:
- Hamza Nahoui, MD
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Oslo, Norsko, 0450
- Oslo University Hospital, Ullevål
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Kontakt:
- Mari Asphjell Björnaas, MD, PhD
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Stavanger, Norsko, 4021
- Stavanger University Hospital
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Kontakt:
- Trond Johan Cooper, MD
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Falun, Švédsko
- Falun Hospital
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Kontakt:
- Jessica Silfverberg, MD
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Gothenburg, Švédsko
- Sahlgrenska University Hospital/Östra
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Kontakt:
- Katarina Glise Sandblad, MD, PhD
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Jönköping, Švédsko
- Ryhov County Hospital
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Kontakt:
- Antheia Kissopoulou, MD, PhD
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Lund, Švédsko
- Skåne University Hospital, Lund
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Kontakt:
- Marcus Ohlsson, MD
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Malmö, Švédsko
- Skåne University Hospital, Malmö
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Kontakt:
- Marcus Ohlsson, MD, PhD
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Mölndal, Švédsko
- Sahlgrenska University Hospital/Mölndal
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Kontakt:
- Louise Martinell, MD, PhD
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Norrtälje, Švédsko
- Norrtälje Hospital
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Kontakt:
- Sune Forsberg, MD, PhD
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Skövde, Švédsko
- Skaraborgs Hospital Skövde
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Kontakt:
- Freyr Einarsson, MD
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Kontakt:
- Erik Ullemark, MD
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Stockholm, Švédsko
- Danderyd Hospital
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Kontakt:
- Nina Olausson, MD, PhD
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Stockholm, Švédsko
- Karolinska University Hospital, Solna
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Kontakt:
- Therese Djärv, MD, PhD
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Stockholm, Švédsko
- Karolinska University Hospital, Huddinge
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Kontakt:
- Therese Djärv, MD, PhD
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Stockholm, Švédsko
- Capio S:t Göran's Hospital
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Kontakt:
- Rickard Markgren, MD, PhD
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Stockholm, Švédsko
- Södersjukhuset, Stockholm South General Hospital
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Kontakt:
- Jacob Hollenberg, MD, PhD
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Umeå, Švédsko
- University Hospital of Umeå
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Kontakt:
- Johanna Pennlert, MD, PhD
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Uppsala, Švédsko
- Uppsala University Hospital
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Kontakt:
- Sofia Vikman, MD, PhD
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Västra Götaland County
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Gothenburg, Västra Götaland County, Švédsko, 413 45
- Sahlgrenska University Hospital
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Kontakt:
- Kristina Svennerholm, MD, PhD
- E-mail: kristina.svennerholm@vgregion.se
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Kontakt:
- Annika Odenstedt
- E-mail: annika.odenstedt@vgregion.se
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
Inclusion Criteria:
- Participant aged 18 years or older.
- Acute pulmonary embolism verified by computed tomography pulmonary angiography or pulmonary angiography. In hemodynamically unstable participants unable to undergo immediate imaging, presumed pulmonary embolism may be diagnosed based on bedside echocardiographic findings consistent with acute right ventricular pressure overload and high clinical suspicion of pulmonary embolism, provided that alternative causes of hemodynamic instability have been reasonably excluded. In such cases, the treating clinician must have independently decided to initiate thrombolytic therapy irrespective of study participation, and confirmatory imaging demonstrating pulmonary embolism must be performed as soon as clinically feasible.
High risk for early death, defined by at least one of the following:
High-risk pulmonary embolism according to European Society of Cardiology criteria:
- Cardiac arrest with return of spontaneous circulation;
- Obstructive shock, defined as systolic blood pressure <90 mmHg or use of vasopressors to maintain systolic blood pressure ≥90 mmHg despite adequate filling status, together with end-organ hypoperfusion such as elevated serum lactate >2 mmol/L, altered mental status, or cold clammy skin;
- Persistent hypotension, defined as systolic blood pressure <90 mmHg or a drop in systolic blood pressure ≥40 mmHg for longer than 15 minutes, not caused by new-onset arrhythmia, hypovolemia, or sepsis.
- Abnormal right ventricular function on echocardiography or computed tomography pulmonary angiography, defined as right ventricular/left ventricular ratio ≥1.0, and elevated cardiac troponin above the local upper reference limit, and acute respiratory failure not primarily caused by underlying lung disease, defined as requiring facemask oxygen supplementation ≥12 L/min, high-flow nasal oxygen, or non-invasive ventilation with FiO2 ≥60% to reach oxygen saturation ≥94%.
- Female participants of childbearing potential must have a negative urine or serum pregnancy test.
Exclusion Criteria:
- Catastrophic pulmonary embolism, defined as ongoing cardiac arrest and/or need for extracorporeal cardiopulmonary resuscitation and/or immediate VA-ECMO as judged by the treating physicians.
- Known hypersensitivity to alteplase or any of its excipients.
Contraindication to systemic thrombolysis with one or more of the following:
- History of hemorrhagic stroke;
- Ischemic stroke within the previous 6 months;
- Central nervous system neoplasm;
- Major trauma, major surgery, or major head injury within the previous 3 weeks;
- Active life-threatening bleeding, bleeding into a critical organ or area, or known severe bleeding diathesis;
- Chronic use of full-dose oral or parenteral anticoagulation before presentation.
- The participant has already received reperfusion treatment for the index pulmonary embolism before randomization, including systemic thrombolysis, surgical embolectomy, or catheter-directed intervention.
- Pregnancy.
- Current participation in another study that would interfere with participation in this trial.
- Any other condition that would put the participant at unacceptable risk from the trial interventions as judged by the treating clinician.
- In countries where required by national regulations: lack of affiliation to a social security system or equivalent health insurance coverage.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Reduced-Dose Alteplase
Participants randomized to reduced-dose systemic thrombolysis will receive alteplase 0.6 mg/kg body weight, up to a maximum dose of 50 mg, administered intravenously over 15 minutes.
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Alteplase 0.6 mg/kg body weight, maximum 50 mg, administered as an intravenous infusion over 15 minutes
Ostatní jména:
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Aktivní komparátor: Full-Dose Alteplase
Participants randomized to standard full-dose systemic thrombolysis will receive alteplase 1.5 mg/kg body weight, up to a maximum dose of 100 mg, administered as a 10 mg intravenous bolus over 1 to 2 minutes followed by a 90 mg intravenous infusion over 2 hours.
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Alteplase 1.5 mg/kg body weight, maximum 100 mg, administered as a 10 mg intravenous bolus over 1 to 2 minutes followed by 90 mg as an intravenous infusion over 2 hours.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Incidence of composite efficacy endpoint
Časové okno: Within 7 days after randomization
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Incidence of a composite endpoint comprising all-cause mortality within 7 days, cardiopulmonary resuscitation and/or veno-arterial extracorporeal membrane oxygenation within 7 days, recurrent pulmonary embolism within 7 days, clinical deterioration within 24 hours, and lack of clinical improvement at 6 hours.
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Within 7 days after randomization
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Key secondary endpoint - Incidence of severe clinically significant bleeding
Časové okno: Within 7 days after randomization
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Incidence of severe clinically significant bleeding, defined as major bleeding according to International Society on Thrombosis and Haemostasis criteria or bleeding requiring urgent medical intervention.
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Within 7 days after randomization
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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All-cause mortality
Časové okno: At 7 days and 30 days after randomization
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Incidence of death from any cause.
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At 7 days and 30 days after randomization
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Pulmonary embolism-related mortality
Časové okno: At 7 days and 30 days after randomization
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Incidence of pulmonary embolism-related death.
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At 7 days and 30 days after randomization
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Cardiopulmonary resuscitation and/or VA-ECMO
Časové okno: Within 7 days after randomization
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Incidence of cardiopulmonary resuscitation and/or veno-arterial extracorporeal membrane oxygenation.
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Within 7 days after randomization
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Incidence of clinical deterioration
Časové okno: Within 24 hours after randomization
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Incidence of life-threatening hemodynamic or respiratory decline requiring cardiopulmonary resuscitation, endotracheal intubation, or VA-ECMO, or an increase in SCAI SHOCK stage after investigational medicinal product administration.
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Within 24 hours after randomization
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Lack of clinical improvement assessed by SCAI SHOCK stage and oxygen requirement
Časové okno: At 6 hours after randomization
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Incidence of unchanged SCAI SHOCK stage or unchanged or rising fraction of inspired oxygen required to maintain oxygen saturation of at least 94%.
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At 6 hours after randomization
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Time to clinical stabilization based on predefined hemodynamic and respiratory criteria
Časové okno: From randomization until clinical stabilization, assessed up to 7 days after randomization
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Time from randomization to the time point at which predefined hemodynamic or respiratory stabilization criteria have been continuously fulfilled for at least 30 minutes
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From randomization until clinical stabilization, assessed up to 7 days after randomization
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Incidence of recurrent pulmonary embolism
Časové okno: At 7 days and 30 days after randomization
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Incidence of objectively confirmed recurrent pulmonary embolism.
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At 7 days and 30 days after randomization
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Initiation of invasive or non-invasive mechanical ventilation
Časové okno: Within 7 days after randomization
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Incidence of initiation of invasive or non-invasive mechanical ventilation.
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Within 7 days after randomization
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Win ratio for efficacy
Časové okno: Within 7 days after randomization
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Win ratio based on all-cause mortality, cardiopulmonary resuscitation and/or VA-ECMO, clinical deterioration, lack of clinical improvement, recurrent pulmonary embolism, and time to clinical stabilization.
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Within 7 days after randomization
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Net clinical benefit
Časové okno: Within 7 days after randomization
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Composite net clinical benefit including severe clinically significant bleeding, all-cause mortality, cardiopulmonary resuscitation and/or VA-ECMO, recurrent pulmonary embolism, clinical deterioration, and lack of clinical improvement.
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Within 7 days after randomization
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Rescue treatment
Časové okno: Before clinical stabilization, up to 7 days after randomization
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Need for rescue treatment, defined as additional alteplase, catheter-directed intervention, surgical embolectomy, or VA-ECMO before stabilization.
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Before clinical stabilization, up to 7 days after randomization
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ICU or high-dependency unit length of stay in days
Časové okno: Within 30 days after randomization
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Length of stay in intensive care unit and/or high-dependency unit.
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Within 30 days after randomization
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Hospital length of stay
Časové okno: Within 30 days after randomization
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Length of hospital stay.
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Within 30 days after randomization
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Major bleeding
Časové okno: At 48 hours, 7 days, and 30 days after randomization
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Incidence of major bleeding according to International Society on Thrombosis and Haemostasis criteria.
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At 48 hours, 7 days, and 30 days after randomization
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Bleeding requiring urgent medical intervention
Časové okno: At 48 hours, 7 days, and 30 days after randomization
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Incidence of severe bleeding requiring urgent medical intervention.
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At 48 hours, 7 days, and 30 days after randomization
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Intracerebral bleeding
Časové okno: Within 7 days after randomization
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Incidence of intracerebral bleeding.
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Within 7 days after randomization
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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All-cause mortality at 12 months
Časové okno: At 12 months after randomization
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Incidence of death from any cause.
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At 12 months after randomization
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At 12 months after randomization
Časové okno: At 12 months after randomization
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Incidence of objectively confirmed recurrent pulmonary embolism.
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At 12 months after randomization
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Persistent dyspnea assessed using the modified Medical Research Council scale
Časové okno: At 3 months and 12 months after randomization
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Persistent dyspnea assessed using the modified Medical Research Council scale.
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At 3 months and 12 months after randomization
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Functional status assessed using the Post-VTE Functional Status Scale
Časové okno: At 3 months and 12 months after randomization
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Functional status assessed using the post-VTE functional status (PVFS) scale.
Scores range from 0 to 4, where 0 indicates no functional limitations and 4 indicates severe functional limitations.
Higher scores indicate worse functional status.
Death before the scheduled assessment is recorded as grade D.
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At 3 months and 12 months after randomization
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Exercise tolerance assessed using the 6-minute walk test
Časové okno: At 3 months and 12 months after randomization
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Exercise tolerance assessed using the 6-minute walk test, reported as distance walked in meters.
A greater distance indicates better exercise tolerance.
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At 3 months and 12 months after randomization
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Persistent right ventricular dysfunction assessed by echocardiography
Časové okno: At 3 months and/or 12 months after randomization
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Persistent right ventricular dysfunction according to echocardiography report, when performed as clinically indicated.
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At 3 months and/or 12 months after randomization
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Pulmonary embolism-specific quality of life assessed using the PEmb-QoL questionnaire
Časové okno: At 3 months and 12 months after randomization
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Pulmonary embolism-specific health-related quality of life assessed using the Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire.
The PEmb-QoL summary score ranges from 0 to 100, with higher scores indicating worse health-related quality of life.
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At 3 months and 12 months after randomization
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Health-related quality of life assessed using EQ-5D-5L
Časové okno: At 3 months and 12 months after randomization
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Health-related quality of life assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) instrument.
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At 3 months and 12 months after randomization
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Chronic thromboembolic pulmonary hypertension
Časové okno: At 12 months after randomization
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Incidence of chronic thromboembolic pulmonary hypertension.
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At 12 months after randomization
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Health care resource utilization
Časové okno: During 12 months after randomization
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Cost of health care resource utilization during the 12-month follow-up period.
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During 12 months after randomization
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Kristina Svennerholm, Sahlgrenska University Hospital / University of Gothenburg
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- Schulman S, Kearon C; Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost. 2005 Apr;3(4):692-4. doi: 10.1111/j.1538-7836.2005.01204.x.
- Wang C, Zhai Z, Yang Y, Wu Q, Cheng Z, Liang L, Dai H, Huang K, Lu W, Zhang Z, Cheng X, Shen YH; China Venous Thromboembolism (VTE) Study Group. Efficacy and safety of low dose recombinant tissue-type plasminogen activator for the treatment of acute pulmonary thromboembolism: a randomized, multicenter, controlled trial. Chest. 2010 Feb;137(2):254-62. doi: 10.1378/chest.09-0765. Epub 2009 Sep 9.
- Konstantinides SV, Meyer G, Becattini C, Bueno H, Geersing GJ, Harjola VP, Huisman MV, Humbert M, Jennings CS, Jimenez D, Kucher N, Lang IM, Lankeit M, Lorusso R, Mazzolai L, Meneveau N, Ni Ainle F, Prandoni P, Pruszczyk P, Righini M, Torbicki A, Van Belle E, Zamorano JL; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS). Eur Heart J. 2020 Jan 21;41(4):543-603. doi: 10.1093/eurheartj/ehz405. No abstract available.
- Sanchez O, Charles-Nelson A, Ageno W, Barco S, Binder H, Chatellier G, Duerschmied D, Empen K, Ferreira M, Girard P, Huisman MV, Jimenez D, Katsahian S, Kozak M, Lankeit M, Meneveau N, Pruszczyk P, Petris A, Righini M, Rosenkranz S, Schellong S, Stefanovic B, Verhamme P, de Wit K, Vicaut E, Zirlik A, Konstantinides SV, Meyer G; PEITHO-3 Investigators. Reduced-Dose Intravenous Thrombolysis for Acute Intermediate-High-risk Pulmonary Embolism: Rationale and Design of the Pulmonary Embolism International THrOmbolysis (PEITHO)-3 trial. Thromb Haemost. 2022 May;122(5):857-866. doi: 10.1055/a-1653-4699. Epub 2021 Oct 31.
- Stevens SM, Woller SC, Kreuziger LB, Bounameaux H, Doerschug K, Geersing GJ, Huisman MV, Kearon C, King CS, Knighton AJ, Lake E, Murin S, Vintch JRE, Wells PS, Moores LK. Antithrombotic Therapy for VTE Disease: Second Update of the CHEST Guideline and Expert Panel Report. Chest. 2021 Dec;160(6):e545-e608. doi: 10.1016/j.chest.2021.07.055. Epub 2021 Aug 2.
- Silver MJ, Giri J, Duffy A, Jaber WA, Khandhar S, Ouriel K, Toma C, Tu T, Horowitz JM. Incidence of Mortality and Complications in High-Risk Pulmonary Embolism: A Systematic Review and Meta-Analysis. J Soc Cardiovasc Angiogr Interv. 2023 Jan 27;2(1):100548. doi: 10.1016/j.jscai.2022.100548. eCollection 2023 Jan-Feb.
- Keller K, Hobohm L, Ebner M, Kresoja KP, Munzel T, Konstantinides SV, Lankeit M. Trends in thrombolytic treatment and outcomes of acute pulmonary embolism in Germany. Eur Heart J. 2020 Jan 21;41(4):522-529. doi: 10.1093/eurheartj/ehz236.
- Goldhaber SZ, Agnelli G, Levine MN. Reduced dose bolus alteplase vs conventional alteplase infusion for pulmonary embolism thrombolysis. An international multicenter randomized trial. The Bolus Alteplase Pulmonary Embolism Group. Chest. 1994 Sep;106(3):718-24. doi: 10.1378/chest.106.3.718.
- Melamed R, Tierney DM, Xia R, Brown CS, Mara KC, Lillyblad M, Sidebottom A, Wiley BM, Khapov I, Gajic O. Safety and Efficacy of Reduced-Dose Versus Full-Dose Alteplase for Acute Pulmonary Embolism: A Multicenter Observational Comparative Effectiveness Study. Crit Care Med. 2024 May 1;52(5):729-742. doi: 10.1097/CCM.0000000000006162. Epub 2024 Jan 3.
- Stadlbauer A, Verbelen T, Binzenhofer L, Goslar T, Supady A, Spieth PM, Noc M, Verstraete A, Hoffmann S, Schomaker M, Hopler J, Kraft M, Tautz E, Hoyer D, Tongers J, Haertel F, El-Essawi A, Salem M, Rangel RH, Hullermann C, Kriz M, Schrage B, Moises J, Sabate M, Pappalardo F, Crusius L, Mangner N, Adler C, Tichelbacker T, Skurk C, Jung C, Kufner S, Graf T, Scherer C, Villegas Sierra L, Billig H, Majunke N, Speidl WS, Zilberszac R, Chiscano-Camon L, Uribarri A, Riera J, Roncon-Albuquerque R Jr, Terauda E, Erglis A, Tavazzi G, Zeymer U, Knorr M, Kilo J, Mobius-Winkler S, Schwinger RHG, Frank D, Borst O, Haberle H, De Roeck F, Vrints C, Schmid C, Nickenig G, Hagl C, Massberg S, Schafer A, Westermann D, Zimmer S, Combes A, Camboni D, Thiele H, Lusebrink E; High-risk P. E. Investigator Group. Management of high-risk acute pulmonary embolism: an emulated target trial analysis. Intensive Care Med. 2025 Mar;51(3):490-505. doi: 10.1007/s00134-025-07805-4. Epub 2025 Feb 25.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
1. prosince 2026
Primární dokončení (Odhadovaný)
31. ledna 2030
Dokončení studie (Odhadovaný)
31. ledna 2031
Termíny zápisu do studia
První předloženo
2. září 2026
První předloženo, které splnilo kritéria kontroly kvality
10. září 2026
První zveřejněno (Aktuální)
14. září 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
17. září 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
14. září 2026
Naposledy ověřeno
1. září 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- REDSTEM
- 2024-515904-37-00 (Ctis)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu IPD
De-identified individual participant data underlying the published results may be shared upon reasonable request after publication.
Access will require approval by the sponsor and principal investigator, a scientifically sound proposal, scientific collaboration with the trial investigators, compliance with applicable ethical, regulatory, data protection, and consent requirements, and a signed data sharing agreement.
Časový rámec sdílení IPD
After publication of the trial results.
Kritéria přístupu pro sdílení IPD
Reasonable request, subject to approval by the sponsor and principal investigator and applicable legal, ethical, and data protection requirements.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .