Platelet function and Treatment in patients with the blood desease Essential Thrombocytosis

Platelet Function and Treatment with ASA in patients with Essential Thrombocytosis - AspiTwice

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002798-39-DK

Enrollment

Unknown

Registered

2015-12-04

Start date

2016-01-26

Completion date

Unknown

Last updated

2016-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential thrombocytosis MedDRA version: 18.1 Level: LLT Classification code 10015495 Term: Essential thrombocytosis System Organ Class: 100000004864

Interventions

Trade Name: ASS Gamma 75 mg Tabletten Product Name: ASS Gamma 75 mg Tabletten Product Code: 6553986.00.00 Pharmaceutical Form: Capsule INN or Proposed INN: Acetylsalicylsäure Other descriptive name: A

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age = 18 Patienter diagnosed with ET Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15

Exclusion criteria

Exclusion criteria: Current treatment with other antithrombotic drug than low dose aspirin Patients at high risk of thrombosis, in whom aspirin can not be interrupted Allergy or intolerance to aspirin Pregnant or nursing Women of childbearing potential who are sexually active and does not using effective contraception Inability to give informed consent

Design outcomes

Primary

Measure	Time frame
Main Objective: The project aims to examine why patients with the disease essential thrombocytosis (ET) are at increased risk of thrombosis, and then to examine if their treatment can be improved. ;Secondary Objective: not applicaple;Primary end point(s): The fraction of newly formed platelets in ET patients compared to healthy individuals . The difference between nadir value of serum thromboxane B 2 after ingestion of 75 mg of aspirin once a day for seven days as compared to the ingestion of 37.5 mg aspirin twice daily in patients with ET.;Timepoint(s) of evaluation of this end point: End of trial	—

Measure

Time frame

Main Objective: The project aims to examine why patients with the disease essential thrombocytosis (ET) are at increased risk of thrombosis, and then to examine if their treatment can be improved. ;Secondary Objective: not applicaple;Primary end point(s): The fraction of newly formed platelets in ET patients compared to healthy individuals . The difference between nadir value of serum thromboxane B 2 after ingestion of 75 mg of aspirin once a day for seven days as compared to the ingestion of 37.5 mg aspirin twice daily in patients with ET.;Timepoint(s) of evaluation of this end point: End of trial

—

Secondary

Measure	Time frame
Secondary end point(s): The fraction of immature platelets, count and mean volume of platelets compared to healthy individuals. Platelet count compared to platelet aggregation in ET patients . Platelet turnover compared to platelet aggregation in ET patients . ;Timepoint(s) of evaluation of this end point: end of trial	—

Countries

Denmark

Contacts

Public ContactCoordinator

Mads C. Larsen

madschristian5270@hotmail.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026