Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
234
Countries
1
Sites
6
Incidental Subsegmental Pulmonary Embolism in cancer patients
To compare withholding anticoagulant treatment versus initiating anticoagulant treatment in cancer patients with incidental subsegmental pulmonary embolism, measuring mortality, bleeding, re-thrombosis, cancer treatment continuation, and quality of life.
Key facts
- Sponsor
- Region Hovedstaden
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14], Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2026-06-04
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Tømrermester Jørgen Holm og Hustru Elisa F. Hansens Mindelegat · Jens og Birthe Munksgaards Fond · Danish Cardiovascular Academy · Region Hovedstaden (CardioHGH) · Kræftens Bekæmpelse
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Prophylaxis
To compare withholding anticoagulant treatment versus initiating anticoagulant treatment in cancer patients with incidental subsegmental pulmonary embolism, measuring mortality, bleeding, re-thrombosis, cancer treatment continuation, and quality of life.
Conditions and MedDRA coding
Incidental Subsegmental Pulmonary Embolism in cancer patients
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 26.0 | LLT | 10088583 | Peripheral pulmonary embolism | 100000004848 |
| 25.0 | LLT | 10087181 | Asymptomatic pulmonary embolism | 100000004848 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- 1 Active cancer
- 2 Age more than or equal to 18
- 3 Less than or equal to three incidental SSPEs detected on routine imaging
- 4 Planned routine follow-up CT scan within 3-4 months
- 5 Able to provide informed consent
- 6 Access to smartphone (participant or family member)
Exclusion criteria 8
- 1 Other indications for anticoagulation treatment
- 2 Currently receiving anticoagulation treatment
- 3 Clinical signs of deep venous thrombosis
- 4 Previous venous thromboembolism (within 10 years)
- 5 Immobilisation > 5 consecutive days
- 6 Cancer surgery within the past 1 month
- 7 Inability to read and speak Danish sufficiently for informed consent and study participation
- 8 Pregnancy
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- WIN ratio of a composite hierarchical endpoint assessed over follow-up including: 1) all-cause mortality 2) clinical pulmonary embolism verified by imaging 3) major bleeding as defined by the International Society on Thrombosis and Haemostasis 4) clinically relevant non-major bleeding as defined by the International Society on Thrombosis and Haemostasis
Secondary endpoints 5
- Clinically relevant bleeding (major bleeding + CRNMB based on the ISTH- definition)
- Venous thromboembolism other than pulmonary embolism verified by imaging
- Progression, stability or resolution of thrombosis on imaging, assessed by two independent radiologists
- Discontinuation of cancer treatment related to pulmonary embolism or pulmonary embolism treatment
- Quality of life assessed by the EuroQol 5-Dimension 5-level (EQ-5D-5L), pulmonary embolism quality of life questionnaire (PEmb-QoL) and the European Organisation for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ C30)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 6
SCP12518807 · ATC
- Active substance
- Dalteparin Sodium
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 18000 IU/Kg iu/kilogram
- Max total dose
- 2160000 IU/Kg iu/kilogram
- Max treatment duration
- 4 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AB04 — DALTEPARIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP125024106 · ATC
- Active substance
- Tinzaparin Sodium
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 175 IU/Kg iu/kilogram
- Max total dose
- 21000 IU/Kg iu/kilogram
- Max treatment duration
- 4 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AB10 — TINZAPARIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP100377272 · ATC
- Active substance
- Lactose Monohydrate
- Substance synonyms
- LACTOSE hydrate
- Route of administration
- ORAL
- Max daily dose
- 30 mg milligram(s)
- Max total dose
- 3600 mg milligram(s)
- Max treatment duration
- 4 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AF01 — RIVAROXABAN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP112628460 · ATC
- Active substance
- Apixaban
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 2400 mg milligram(s)
- Max treatment duration
- 4 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AF02 — APIXABAN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP118777247 · ATC
- Active substance
- Enoxaparin Sodium
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 2 mg/Kg milligram(s)/kilogram
- Max total dose
- 240 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 4 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AB05 — ENOXAPARIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP125068526 · ATC
- Active substance
- Edoxaban Tosylate Monohydrate
- Substance synonyms
- Edoxaban tosilate monohydrate
- Route of administration
- ORAL
- Max daily dose
- 60 mg milligram(s)
- Max total dose
- 7200 mg milligram(s)
- Max treatment duration
- 4 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AF03 — EDOXABAN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Hovedstaden
- Sponsor organisation
- Region Hovedstaden
- Address
- Borgmester Ib Juuls Vej 1
- City
- Herlev
- Postcode
- 2730
- Country
- Denmark
Scientific contact point
- Organisation
- Region Hovedstaden
- Contact name
- Ali Al-Alak
Public contact point
- Organisation
- Region Hovedstaden
- Contact name
- Ali Al-Alak
Locations
1 EU/EEA country · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Authorised, recruitment pending | 234 | 6 |
| Rest of world | — | 0 | — |
Investigational sites
Region Hovedstaden
Oncology, Borgmester Ib Juuls Vej 1, 2730, Herlev
Region Syddanmark
Oncology, Lille Grundet Hulvej 25, 7100, Vejle
Region Hovedstaden
Oncology, Blegdamsvej 9, 2100, Copenhagen Oe
Region Syddanmark
Oncology, J.B. Winsloews Vej 18, 5000, Odense C
Region Hovedstaden
Oncology, Kongens Vaenge 2, 3400, Hilleroed
Region Nordjylland
Oncology, Moelleparkvej 10, 9000, Aalborg
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 11 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | d1_protocol_2025_524110_28_00 | 3 |
| Recruitment arrangements (for publication) | k1_recruitment_arrangements | 2 |
| Subject information and informed consent form (for publication) | l1_icf | 1 |
| Subject information and informed consent form (for publication) | l1_sis_redacted | 2 |
| Subject information and informed consent form (for publication) | l2_dine_rettigheder_som_forsgsperson | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | e2_smpc_apixaban | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | e2_smpc_dalteparin | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | e2_smpc_edoxaban | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | e2_smpc_enoxaparin | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | e2_smpc_rivaroxaban | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | e2_smpc_tinzaparin | N/A |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-03-16 | Denmark | Acceptable 2026-06-03
|
2026-06-04 |