Clinical trial • Not applicable • Neurology | Cardiology

Clopidogrel for Stroke

Not applicable trial of Clopidogrel for Stroke.

Overview

Trial Therapeutic Area
Neurology | Cardiology
Trial Disease
Stroke
Trial Stage
Not applicable
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
09-07-2024
First CTIS Authorization Date
04-08-2024

Trial design

Continuation of antiplatelet therapy (comparator): Plavix (Clopidogrel) 75 mg film-coated tablets, oral; Acetylsalicylic acid (carbasalate calcium) up to 80 mg oral daily; Dipyridamole (may be combined with acetylsalicylic acid in product) up to 400 mg oral daily.-controlled Not applicable trial across 29 sites in Netherlands.

Comparator
Continuation of antiplatelet therapy (comparator): Plavix (Clopidogrel) 75 mg film-coated tablets, oral; Acetylsalicylic acid (carbasalate calcium) up to 80 mg oral daily; Dipyridamole (may be combined with acetylsalicylic acid in product) up to 400 mg oral daily.
Target Sample Size
1316

Eligibility

Recruits 1316 No vulnerable populations selected; participants are adults (age 18-49). Informed consent is provided by the participants. Subject information and informed consent form for adults available (document: L1_SIS and ICF adults_redacted) and additional subject information materials for low literacy are available (document: L2_Other subject information material_low litteracy)..

Vulnerable Population
No vulnerable populations selected; participants are adults (age 18-49). Informed consent is provided by the participants. Subject information and informed consent form for adults available (document: L1_SIS and ICF adults_redacted) and additional subject information materials for low literacy are available (document: L2_Other subject information material_low litteracy).

Inclusion criteria

  • {"criterion_text":"- First ever ischaemic stroke, or TIA with evidence of ischaemia on imaging, 3-10 years prior to study participation\n- Age 18-49 years at the time of TIA/ischaemic stroke\n- Cryptogenic aetiology, defined as no other aetiology after standard work-up according to national and international guidelines for young stroke (imaging of the brain (CT-scan or MRI-scan) and cervical arteries (CTA, MRA or carotid ultrasound), routine blood tests (complete blood count, erythrocyte sedimentation rate, CRP, antiphospholipid antibodies), ECG, at least 24 hours cardiac rhythm monitoring and transthoracic/transesophageal echocardiography)."}

Exclusion criteria

  • {"criterion_text":"- History of MI, coronary revascularisation or documented peripheral arterial disease\n- Other indication for antiplatelet therapy\n- Indication for oral anticoagulants or low molecular weight heparin\n- Recurrent ischaemic event at any time after the index event\n- Any stenosis of intracranial or cervical artery at time of stroke\n- Two or more risk factors for atherosclerotic disease according to the following definitions: • arterial hypertension (treated or known blood pressure before stroke >140/90 mm Hg) • diabetes mellitus (treated or known blood fasting glucose >7 mmol/l) • current smoking (or smoking stopped within the last 6 months), • hypercholesterolaemia (treated or known low-density lipoprotein before the stroke >160 mg/dl or 4, mmol/l)\n- Any condition that prevents long-term follow-up"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- A composite endpoint of major vascular events, defined as TIA with imaging confirmation, stroke, myocardial infarction, or death from vascular causes.","definition_or_measurement_approach":"A composite endpoint of major vascular events, defined as TIA with imaging confirmation, stroke, myocardial infarction, or death from vascular causes."}

Secondary endpoints

  • {"endpoint_text":"- Major bleeding\n- All-cause mortality\n- Cost-effectiveness\n- Quality of life","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
1316
Recruitment Window Months
84
Consent Approach
Informed consent obtained from adult participants (age 18-49). Subject information and informed consent form for adults provided (document: L1_SIS and ICF adults_redacted). Additional information materials for low literacy are available (document: L2_Other subject information material_low litteracy). No assent process for minors (no paediatric participants).

Geography

Total Number Of Sites
29
Total Number Of Participants
1316

Netherlands

Earliest CTIS Part Ii Submission Date
03-08-2024
Latest Decision Or Authorization Date
12-02-2026
Processing Time Days
558
Number Of Sites
29
Number Of Participants
1316

Sites

Site Name
Radboud universitair medisch centrum / RADBOUDUMC
Department Name
Neurology
Contact Person Name
Frank-Erik de Leeuw
Site Name
Haga Hospital
Department Name
Neurology
Contact Person Name
Jurgen Piet
Contact Person Email
j.piet@hagaziekenhuis.nl
Site Name
Leids Universitair Medisch Centrum (LUMC)
Department Name
Neurology
Contact Person Name
Nyika Kruyt
Contact Person Email
n.d.kruyt@lumc.nl
Site Name
Gelre Hospitals
Department Name
Neurology
Contact Person Name
Mayte van Alebeek
Contact Person Email
me.vanalebeek@gmail.com
Site Name
Stichting Elisabeth-Tweesteden Ziekenhuis
Department Name
Neurology
Contact Person Name
Julia van Tuijl
Contact Person Email
j.vantuijl@etz.nl
Site Name
Medisch Centrum Leeuwarden B.V.
Department Name
Neurology
Contact Person Name
Frank van Rooij
Contact Person Email
Wetenschap@mclacademie.nl
Site Name
Haaglanden Medisch Centrum Stichting
Department Name
Neurology
Contact Person Name
Ido van den Wijngaard
Site Name
Medisch Spectrum Twente
Department Name
Neurology
Contact Person Name
Renate Arntz
Contact Person Email
ResearchOC@mst.nl
Site Name
Deventer Ziekenhuis
Department Name
Neurology
Contact Person Name
MH Schipper
Contact Person Email
m.schipper@dz.nl
Site Name
Sint Franciscus Vlietland Groep Stichting
Department Name
Neurology
Contact Person Name
Tom Den heijer
Site Name
Alrijne Zorggroep Stichting
Department Name
Neurology
Contact Person Name
E de Schryver
Contact Person Email
infro@alrijne.nl
Site Name
Albert Schweitzer Ziekenhuis
Department Name
Neurology
Contact Person Name
Henk Kerkhoff
Contact Person Email
wetenschap@asz.nl
Site Name
Catharina Ziekenhuis Stichting
Department Name
Neurology
Contact Person Name
Inge van Uden
Site Name
Jeroen Bosch Ziekenhuis Stichting
Department Name
Neurology
Contact Person Name
Marian Van Zagten
Contact Person Email
m.van.zagten@jbz.nl
Site Name
Spaarne Gasthuis Stichting
Department Name
Neurology
Contact Person Name
Frank De Beer
Contact Person Email
fdebeer@gmail.com
Site Name
Bernhoven B.V.
Department Name
Neurology
Contact Person Name
Joy Lion
Contact Person Email
j.lion@bernhoven.nl
Site Name
Isala Klinieken Stichting
Department Name
Neurology
Contact Person Name
Clemens Kersten
Contact Person Email
c.a.b.a.kersten@isala.nl
Site Name
Reinier de Graaf Groep
Department Name
Neurology
Contact Person Name
Leo Aerden
Contact Person Email
wetenschapsbureau@rdgg.nl
Site Name
Amphia Hospital
Department Name
Neurology
Contact Person Name
Anouk Van Norden
Contact Person Email
avannorden@amphia.nl
Site Name
Academisch Medisch Centrum
Department Name
Neurology
Contact Person Name
Paul Nederkoorn
Contact Person Email
p.j.nederkoorn@amsterdamumc.nl
Site Name
Canisius Wilhelmina Ziekenhuis
Department Name
Neurology
Contact Person Name
Willemijn Leen
Contact Person Email
w.leen@cwz.nl
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Neurology
Contact Person Name
Bob Roozenbeek
Contact Person Email
b.roozenbeek@erasmusmc.nl
Site Name
Universiteit Maastricht
Department Name
Neurology
Contact Person Name
R Oostenbrugge
Contact Person Email
r.van.oostenbrugge@mumc.nl
Site Name
Stichting OLVG
Department Name
Neurology
Contact Person Name
Renske Van den Berg-Vos
Contact Person Email
r.vandenberg-vos@olvg.nl
Site Name
Universitair Medisch Centrum Groningen
Department Name
Neurology
Contact Person Name
Maarten Uyttenboogaart
Contact Person Email
m.uyttenboogaart@umcg.nl
Site Name
Zuyderland Medisch Centrum Stichting
Department Name
Neurology
Contact Person Name
Tobien Schreuder
Contact Person Email
t.schreuder@zuyderland.nl
Site Name
Rijnstate Ziekenhuis Stichting
Department Name
Neurology
Contact Person Name
Sarah Vermeer
Contact Person Email
Svermeer@rijnstate.nl
Site Name
Universitair Medisch Centrum Utrecht
Department Name
Neurology
Contact Person Name
Bart van der Worp
Contact Person Email
h.b.vanderworp@umcutrecht.nl
Site Name
Maasstad Ziekenhuis Stichting
Department Name
Neurology
Contact Person Name
Wilad Moudrous

Sponsor

Primary sponsor

Full Name
Stichting Radboud universitair medisch centrum
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Netherlands

Investigational products

Investigational Product Name
Clopidogrel Viatris 75 mg film-coated tablets
Active Substance
Clopidogrel
Modality
Small molecule
Routes Of Administration
ORAL
Route
Oral
Authorisation Status
Authorised
Maximum Dose
75 mg
Investigational Product Name
Plavix 75 mg film-coated tablets
Active Substance
Clopidogrel
Modality
Small molecule
Routes Of Administration
ORAL
Route
Oral
Authorisation Status
Authorised
Maximum Dose
75 mg
Investigational Product Name
ACETYLSALICYLIC ACID
Active Substance
Carbasalate calcium (acetylsalicylic acid)
Modality
Small molecule
Routes Of Administration
ORAL
Route
Oral
Authorisation Status
Authorised
Maximum Dose
80 mg
Investigational Product Name
DIPYRIDAMOLE
Active Substance
Dipyridamole (often combined with acetylsalicylic acid in product)
Modality
Small molecule
Routes Of Administration
ORAL
Route
Oral
Authorisation Status
Authorised
Maximum Dose
400 mg

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