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SOCRATES Trial in Stroke

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SOCRATES: Acute Stroke Or Transient Ischaemic Attack Treated with Aspirin or Ticagrelor and Patient Outcomes 

Sponsor: AstraZeneca
Investigators: Viken Babikian MD (principal), Carlos Kase MD, Jose Romero MD, Thanh Nguyen MD

News Release 3/23/16 - AstraZeneca announced the top-line results of the SOCRATES trial, assessing the efficacy of Brilinta/Brilique (ticagrelor) 90mg tablets twice daily, when compared to aspirin 100mg once daily in patients with acute ischaemic stroke or transient ischaemic attack (TIA). The primary efficacy endpoint of time to first occurrence of any event from the composite of stroke (ischaemic or haemorrhagic), myocardial infarction (MI, also known as heart attack) and death was not met. Fewer events were observed on Brilinta/Brilique versus the comparator in the overall trial population but the trend did not reach statistical significance.

Sponsor: AstraZeneca
Principal Investigator: Viken Babikian, MD
Sub-investigators: Jose Romero MD, Thanh Nguyen MD, Carlos Kase MD, Hesham Masoud MD, Hugo Aparicio MD

Summary: An ischemic stroke occurs when a blood vessel that supplies blood to the brain is blocked by a blood clot. This condition will cause lack of oxygen, and the brain cells can die, which may result in permanent damage. A TIA is a condition that produces stroke-like symptoms, like sudden weakness on one side of the body or trouble speaking, but the symptoms are temporary. A TIA could be a warning that a true stroke may happen in the future if something is not done to prevent it. This study is being carried out to compare the effect of the new drug, ticagrelor, given twice daily compared to Acetylsalicylic acid (ASA), also called aspirin, given once daily for the prevention of death, heart attack and stroke in patients with acute ischaemic stroke or TIA.

Purpose: The primary objective of the study is to compare the effect of 90-day treatment with ticagrelor (180 mg [two 90 mg tablets] loading dose on Day 1 followed by 90 mg twice daily maintenance dose for the remainder of the study) vs acetylsalicylic acid (ASA)-aspirin (300 mg [three 100 mg tablets] loading dose on Day 1 followed by 100 mg once daily maintenance dose for the remainder of the study) for the prevention of major vascular events (composite of stroke, myocardial infarction [MI], and death) in patients with acute ischaemic stroke or transient ischaemic attack (TIA).

Inclusion Criteria (highlights only):

  • Men or women equal or elder 40 years of age
  • Either acute ischemic stroke or high-risk TIA as defined here and randomization occurring within 24 hours after onset of symptoms

Status: Actively enrolling patients

More information and exclusion criteria on SOCRATES