A RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, INTERNATIONAL, MULTICENTRE, PHASE III STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF TICAGRELOR AND ASA COMPARED WITH ASA IN THE PREVENTION OF STROKE AND DEATH IN PATIENTS WITH ACUTE ISCHAEMIC STROKE OR TRANSIENT ISCHAEMIC ATTACK

• Register: RPEC
• Last refreshed on: 4 September 2023
• Main ID: PER-036-17
• Date of registration: 09/02/2018
• Prospective Registration: No
• Primary sponsor: AstraZeneca AB,
• Public title: A RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, INTERNATIONAL, MULTICENTRE, PHASE III STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF TICAGRELOR AND ASA COMPARED WITH ASA IN THE PREVENTION OF STROKE AND DEATH IN PATIENTS WITH ACUTE ISCHAEMIC STROKE OR TRANSIENT ISCHAEMIC ATTACK
• Scientific title: A RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, INTERNATIONAL, MULTICENTRE, PHASE III STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF TICAGRELOR AND ASA COMPARED WITH ASA IN THE PREVENTION OF STROKE AND DEATH IN PATIENTS WITH ACUTE ISCHAEMIC STROKE OR TRANSIENT ISCHAEMIC ATTACK
• Date of first enrolment: 15/01/2018
• Target sample size: 185
• Recruitment status: Complete
• URL: https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=036-17
• Study type: Interventional
• Study design: This is a randomised, placebo-controlled, double-blind, parallel-group, international, multicentre Phase III study to test the hypothesis that ticagrelor and acetylsalicylic acid (ASA) is superior to ASA in preventing stroke and death in patients with acute ischaemic stroke (AIS) or transient ischaemic attack (TIA).
• Phase: III

Countries of recruitment

Arabia Saudi, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, China, Czech Republic, Germany, Hungary, Italy, Mexico, Poland, Romania, Slovakia, Spain, Sweden, Taiwan, Thailand, Ukraine, Vietnam

Contacts

• Name: Ursula Chavez Rodriguez-Frias
• Affiliation: ASTRAZENECA PERU S.A.

• Name: Ursula Chavez Rodriguez-Frias
• Affiliation: ASTRAZENECA PERU S.A.

Key inclusion & exclusion criteria

Inclusion criteria:
For inclusion in the study, patients should fulfil the following criteria:
1. Provision of signed informed consent prior to any study-specific procedure
2. ≥40 years of age
3. Acute onset of cerebral ischaemia due to
(a) AIS with NIHSS ≤5. AIS is defined as acute onset of neurological deficit attributed to focal brain ischaemia, and either of the following:
 Persistent signs or symptoms of the ischaemic event at the time of randomisation, OR
 Acute ischaemic brain lesion documented before randomisation by computed tomography (CT) scan or magnetic resonance imaging (MRI) (diffusion-weighted imaging) and that could account for the clinical presentation
(b) High-risk TIA, defined as neurological deficit of acute onset attributed to focal ischaemia of the brain by history or examination with complete resolution of the deficit, and at least one of the following:
 ABCD2 score ≥6 and TIA symptoms not limited to isolated numbness, isolated visual changes, or isolated dizziness/vertigo
 Symptomatic intracranial arterial occlusive disease that could account for the clinical presentation, documented by transcranial Doppler or vascular imaging and defined as at least 50% narrowing in the diameter of the vessel lumen
 Internal carotid arterial occlusive disease that could account for the clinical presentation, documented by Doppler, ultrasound, or vascular imaging and defined as at least 50% narrowing in diameter of the vessel lumen

Please refer to page 17 on CSP

Exclusion criteria:
Patients fulfilling any of the exclusion criteria must not be randomised.
1. Need for or an anticipated need for any of the following:
(a) Dual antiplatelet therapy with ASA and P2Y12 inhibitors (including patients with carotid artery stenting and percutaneous coronary intervention)
(b) Antiplatelets other than ASA (eg, GPIIb/IIIa inhibitors, clopidogrel, ticlopidine, prasugrel, dipyridamole, ozagrel, cilostazol, ticagrelor) and other antithrombotic agents with antiplatelet effects, including traditional/herbal medicine agents
(c) Anticoagulants (eg, warfarin, oral thrombin and factor Xa inhibitors, bivalirudin, hirudin, argatroban, fondaparinux, or unfractionated heparin and long-term treatment with low-molecular weight heparins). Short-term treatment (≤7 days) with low-dose low-molecular weight heparin may be used in immobilised patients at the discretion of the Investigator

Please refer to page 18 on CSP


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

I63

-I63 -I67

I67

Intervention(s)

At randomisation (Visit 1/Day 1), eligible patients will be randomly assigned to 1 of 2 treatments: ticagrelor or placebo. Treatments will be given orally with loading doses on Day 1 followed by maintenance treatment until Visit 3/Day 30. Patients will be treated with:
• A loading dose of ticagrelor (2 tablets ticagrelor 90 mg) on Day 1, followed by ticagrelor 90 mg twice daily, OR
• A loading dose of placebo (2 tablets matching ticagrelor 90 mg) on Day 1, followed by placebo (matching ticagrelor 90 mg) twice daily.

Secondary ID(s)

2016-004232-37

Source(s) of Monetary Support

Astrazeneca AB

Ethics review

Status: Approved
Approval date: 11/10/2017
Contact:

[e-mail]

Via Libre

4331396

[e-mail]

Status: Approved
Approval date: 20/11/2017
Contact:

[e-mail]

Hospital Cayetano Heredia

97254626

[e-mail]

Status: Approved
Approval date: 21/11/2017
Contact:

[e-mail]

Via Libre

4331396

[e-mail]

Status: Approved
Approval date: 05/12/2017
Contact:

[e-mail]

Hospital Nacional Arzobispo Loayza

88339014 - 3301677

[e-mail]

Status: Approved
Approval date: 12/12/2017
Contact:

[e-mail]

Via Libre

4331396

[e-mail]

Status: Approved
Approval date: 19/01/2018
Contact:

[e-mail]

Hospital Nacional Alberto Sabogal Sologuren

4297744 anexo 5388

[e-mail]

Status: Approved
Approval date: 23/01/2018
Contact:

[e-mail]

Via Libre

4331396

[e-mail]

Status: Approved
Approval date: 06/02/2018
Contact:

[e-mail]

Via Libre

4331396

[e-mail]

Status: Approved
Approval date: 01/06/2018
Contact:

[e-mail]

Hospital Nacional Guillermo Almenara Irigoyen - EsSalud

999436950

[e-mail]

Results

• Results available: Yes
• Date Completed: 05/12/2019