No registrations found.
ID
Source
Brief title
Health condition
Chronic Thromboembolic Pulmonary Hypertension (CTEPH), Chronic Thromboembolic Disease (CTED)
Sponsors and support
Intervention
Outcome measures
Primary outcome
A composite of periprocedural bleeding (life-threatening or disabling bleeding, vascular injury or access site complications) and lung injury within 24 hours after BPA on a per-session basis.
Secondary outcome
- long-term safety of anticoagulant medicine in CTEPH/CTED patients receiving BPA on a per-patient basis.
- long-term efficacy of anticoagulant medicine and quality of life (QoL) in CTEPH/CTED patients receiving BPA on a per-patient basis.
Background summary
Rationale: Historically, all patients with chronic thromboembolic pulmonary hypertension (CTEPH) and chronic thromboembolic disease (CTED) were treated with vitamin K antagonists (VKAs). Nowadays, the use of direct oral anticoagulants (DOACs) is increasing. Nevertheless, it is unclear if DOACs are superior or inferior compared to VKAs in CTEPH patients receiving balloon pulmonary angioplasty (BPA) regarding (peri-procedural) bleeding, long-term (thrombotic) complications and clinical outcome.
Objective: We evaluate the safety and efficacy of DOACs versus VKAs in CTEPH/CTED patients receiving BPA. The effect of anticoagulant type on long-term safety and efficacy and quality of life in these patients is evaluated on a per-patient basis.
Study design: Multicentre, randomized controlled, open-label pilot trial.
Study population: All consecutive patients with an established CTEPH/CTED diagnosis and accepted for BPA treatment are eligible for inclusion in this study. Patients with an indication for a specific anticoagulation treatment, a high bleeding risk or a life-expectancy less than 1 year are excluded.
Intervention: The patients will be randomized to VKA or DOAC prior to the first BPA procedure.
Main study parameters/endpoints: The primary endpoint is the combination of periprocedural bleeding (life-threatening or disabling bleeding, vascular injury or access site problems) and lung injury within 24 hours after BPA, on a per-session basis. In addition, other (long-term) safety and efficacy endpoints will be assessed per-patient.
Study objective
It is unclear if DOACs are superior or inferior compared to VKAs in CTEPH/CTED patients regarding (peri-procedural) bleeding and long-term (thrombotic) complications.
Study design
After each BPA and at 3,6, 12 and 18 months
Intervention
VKA versus DOAC in CTEPH/CTED patients receiving BPA
Liza van de Groep
+31 (0)88-3201309
l.van.de.groep@antoniusziekenhuis.nl
Liza van de Groep
+31 (0)88-3201309
l.van.de.groep@antoniusziekenhuis.nl
Inclusion criteria
- Established CTEPH or CTED diagnosis according to the guideline(12), with at least 3 months of anticoagulation treatment.
- Inoperable patients, patients reluctant to undergo surgery or patients with residual PH after PEA and accepted for BPA treatment.
- Accessible thromboembolic lesions for BPA.
Exclusion criteria
- Operable CTEPH or CTED patients accepted for PEA.
- Contra-indications for BPA: right-sided mechanical heart valve, thrombus or myxoma in the right atrium or right-sided valvular endocarditis.
- Contra-indications for DOAC treatment: e.g. mechanical heart valves, myocardial thrombus, triple positive antiphospholipid syndrome, morbid obesity and (status after) bariatric treatment or major gastrointestinal resections and combination with CYP3A4 inhibitors and inductors. Anticoagulation dosage should be adjusted depending on renal function and drug interaction.
- High risk patients for bleeding complications: previous life-threatening bleeding (e.g. intracranial bleeding), age >80 years or pulmonary vascular resistance > 10 woods units (WU).
- Life-expectancy <1 year.
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9222 |
| CCMO | NL75523.100.20 |
| OMON | NL-OMON53991 |