Overview
Sponsor-declared trial summary
Immune thRombocytopenia
To assess the residual platelet function after 75 mg aspirin intake (H24)
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Toulouse
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Trial duration
- 16 Jan 2023 → 15 Jan 2025
- Decision date (initial)
- 2024-05-28
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-513846-13-00
- EudraCT number
- 2020-000968-30
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy
To assess the residual platelet function after 75 mg aspirin intake (H24)
Secondary objectives 1
- To assess the kinetics of platelet function after daily 75 mg aspirin intake and the relation with arterial thrombosis
Conditions and MedDRA coding
Immune thRombocytopenia
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- adult patients (sup 18-year-old)
- non-treated ITP or ITP with stable treatment (at least 1 month)
- treated with aspirin daily for a cardiovascular disease
- stable platelet count < 100 x 109/L
- at least one month following an arterial thrombosis; no other antiplatelet drug
- female patient with childbearing potential must have acceptable method of birth control
- affiliated or benefiting from public health insurance.
Exclusion criteria 3
- opposition to participate
- adults Under guardianship or other legal protection, deprived of their liberty by judicial or administrative decision
- pregnancy or breastfeeding
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Platelet production of thromboxane B2 (TXB2) 24 hours after a 75 mg aspirin intake
Secondary endpoints 4
- Platelet function by light transmission agregometry (LTA) 24 four hours after a 75 mg aspirin intake;
- platelet production of TXB2 by lipidomic and platelet function by LTA at H2 and H12 after a75 mg aspirin intake
- arterial thromboses identified in the CARMEN registry.
- Measurement of platelet TXB2 synthesis after platelet stimulation by arachidonic acid at H2 and H12 from a dose of 75 mg of AAS. 12-HETE produced by lymphoxygenase and quantified in the same mass spectrometry profile as TXB2 will also be taken into account.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
KARDEGIC 75 mg, poudre pour solution buvable en sachet-dose
PRD432444 · Product
- Active substance
- D,L-Lysine Acetylsalicylate
- Substance synonyms
- DL-lysine acetylsalicylate, ASPIRIN DL-LYSINE, 2-ACETYLOXYBENZOATE (5-AMINO-5-CARBOXY-PENTYL)AZANIUM
- Pharmaceutical form
- ORAL SOLUTION
- Route of administration
- ORAL
- Max daily dose
- 75 mg milligram(s)
- Max total dose
- 1200 mg milligram(s)
- Max treatment duration
- 16 Day(s)
- Authorisation status
- Authorised
- ATC code
- B01AC06 — ACETYLSALICYLIC ACID
- Marketing authorisation
- 34009 347 441 9 8
- MA holder
- SANOFI WINTHROP INDUSTRIE
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire De Toulouse
- Sponsor organisation
- Centre Hospitalier Universitaire De Toulouse
- Address
- 2 Rue Viguerie
- City
- Toulouse
- Postcode
- 31300
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire De Toulouse
- Contact name
- clinical research project manager
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Toulouse
- Contact name
- clinical research project manager
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 10 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2023-01-16 | 2023-01-16 | 2025-01-15 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| Résumé des résultats ASPIRE SUM-130633
|
2026-04-23T15:27:17 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Résumé Grand public ASPIRE | 2026-04-23T15:27:52 | Submitted | Laypersons Summary of Results |
Documents 2 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | Resume grand public_FR_ASPIRE | 1 |
| Summary of results (for publication) | Resume des resultats_EN_ASPIRE | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-23 | France | Acceptable 2024-05-27
|
2024-05-28 |