In short
Ticlopidine hydrochloride is a chemically synthesised antiplatelet medicine authorised in Italy and used to prevent blood clots. It is being tested in one authorised Phase 3 trial with 1,506 participants for non-cardioembolic ischemic stroke. The trial compares ticlopidine with acetylsalicylic acid and clopidogrel in a gender-stratified design. The aim is to see whether tailored antiplatelet prescribing lowers the 12-month rate of major cardiovascular events.
Key points
- Ticlopidine hydrochloride is an oral antiplatelet medicine authorised in Italy.
- It is being studied in non-cardioembolic ischemic stroke.
- The trial is Phase 3 and has 1,506 participants.
- The primary outcome is the 12-month incidence of ischemic stroke, myocardial infarction, or cardiovascular death.
- The trial is gender-stratified and randomised.
- The trial status is Authorised, meaning it can begin recruiting.
What is ticlopidine hydrochloride?
Ticlopidine hydrochloride is a chemically synthesised substance classified as an antiplatelet medicine under the ATC code B01AC05. It is authorised as a medicine in Italy, where the authorisation record is IT 033208012 and the authorisation holder is Mylan S.p.A. The product name in the trial record is Ticlopidina Mylan Generics 250 mg compresse rivestite. In the United Kingdom, the NHS dm+d browser lists ticlopidine hydrochloride as an ingredient with a virtual medicinal product of 250 mg tablets. The substance appears in the CTIS registry under the therapeutic area of cardiovascular diseases.
How does ticlopidine hydrochloride work?
Ticlopidine hydrochloride acts on platelets, the blood cells that help blood to clot. A review of the available data describes a rapid, dose-dependent onset of effect on platelet function, together with a time-dependent effect on bleeding. The antiplatelet effect appears to come from a direct action on circulating platelets, and a metabolite called a 2-keto derivative may also contribute. By reducing platelet activity, ticlopidine makes it harder for unwanted blood clots to form inside blood vessels.
Which conditions is ticlopidine hydrochloride used or studied for?
Ticlopidine hydrochloride is an antiplatelet medicine. In the CTIS registry it belongs to the cardiovascular diseases area. The current registered clinical trial studies it in one condition:
- Non-cardioembolic ischemic stroke — a type of stroke caused by a blood clot that blocks a brain artery, where the clot did not come from the heart.
How is ticlopidine hydrochloride given?
Ticlopidine hydrochloride is given by mouth as a coated tablet. The pharmaceutical form recorded in the CTIS product data is a coated tablet, and the route of administration is oral. In the trial, the ticlopidine product is Ticlopidina Mylan Generics 250 mg compresse rivestite, a 250 mg coated tablet. The NHS dm+d browser also lists ticlopidine 250 mg tablets as a virtual medicinal product.
What do the clinical trials show?
One registered clinical trial investigates ticlopidine hydrochloride as the test substance. The trial is a Phase 3, randomised, controlled study in non-cardioembolic ischemic stroke. It is gender-stratified, meaning participants are divided by sex to allow separate analysis. The study has 1,506 participants and is currently authorised, meaning it has received approval and can begin recruiting.
The trial compares three oral antiplatelet medicines: ticlopidine 250 mg, acetylsalicylic acid 100 mg, and clopidogrel 75 mg. The primary outcome is the 12-month cumulative incidence, or time to first event, of a composite of ischemic stroke, myocardial infarction, or cardiovascular death. The aim is to demonstrate that a tailored prescription of antiplatelet drugs can cut the rate of 12-month major cardiovascular events compared to usual care.
What side effects are known?
The provided sources do not report a side-effect profile for ticlopidine hydrochloride. The pharmacodynamic review notes a time-dependent effect on bleeding, which reflects the antiplatelet action of the medicine rather than a list of adverse events.