FDA approves ticagrelor for multiple indications in cardiology and neurology

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FDA Published May 14, 2026 Medically reviewed May 14, 2026 DOI ↗ By Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

Key Takeaway

Consider ticagrelor for ACS, high-risk CAD, or acute ischemic stroke/TIA based on FDA approval from prior trials.

The FDA has approved ticagrelor (Brilinta) for three distinct indications: patients with acute coronary syndrome (ACS) or a history of myocardial infarction; patients with coronary artery disease at high risk for a first MI or stroke, with efficacy established in those with type 2 diabetes; and patients with acute ischemic stroke (NIHSS ≤5) or high-risk transient ischemic attack. For the ACS indication, ticagrelor was compared with clopidogrel and found to be superior in reducing the composite of cardiovascular death, MI, and stroke for at least the first 12 months following ACS. Additionally, in ACS patients who received a stent, ticagrelor reduced the risk of stent thrombosis. In patients with CAD, ticagrelor reduced the risk of first MI or stroke. In patients with acute ischemic stroke or high-risk TIA, ticagrelor reduced the risk of stroke. Specific effect sizes, absolute numbers, and confidence intervals were not reported in this approval summary. Safety data, including adverse events and tolerability, were not detailed. Limitations of the approval summary include the lack of reported numerical results and safety information. Clinicians should interpret these approvals based on the referenced clinical trials and consider ticagrelor as an option for appropriate patients.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Brilinta is a P2Y12 platelet inhibitor that inhibits platelet aggregation by blocking the P2Y12 receptor.

Indication & Patient Population

Brilinta is indicated to reduce the risk of cardiovascular death, MI, and stroke in patients with ACS or a history of MI. For at least the first 12 months following ACS, it is superior to clopidogrel. It also reduces the risk of stent thrombosis in patients stented for ACS.

Dosing & Administration

For ACS or history of MI: initiate with a 180 mg loading dose, then 90 mg twice daily for the first year, followed by 60 mg twice daily after one year. Use with aspirin 75-100 mg daily. In patients who have undergone PCI, consider single antiplatelet therapy with Brilinta based on thrombotic vs bleeding risk. For patients unable to swallow tablets, tablets can be crushed and mixed with water.

Key Clinical Trial Data

The PLATO trial (NCT00391872) was a randomized double-blind study comparing Brilinta (N=9333) to clopidogrel (N=9291) in patients with ACS presenting within 24 hours of symptoms. The primary endpoint was the composite of first occurrence of cardiovascular death, non-fatal MI, or non-fatal stroke. Brilinta was superior to clopidogrel for the primary endpoint.

Warnings & Contraindications

Not reported in label.

Place in Therapy

Brilinta is a first-line antiplatelet option for patients with ACS or a history of MI, particularly in the first 12 months where it shows superiority over clopidogrel. It should be used with low-dose aspirin and avoided with other oral P2Y12 inhibitors.

Study Details

Study typeFda approval

PublishedJul 2011

View Original Abstract ↓

1 INDICATIONS AND USAGE BRILINTA is a P2Y 12 platelet inhibitor indicated to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, it is superior to clopidogrel. BRILINTA also reduces the risk of stent thrombosis in patients who have been stented for treatment of ACS. (1.1) to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events. While use is not limited to this setting, the efficacy of BRILINTA was established in a population with type 2 diabetes mellitus (T2DM). (1.2) to reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score ≤5) or high-risk transient ischemic attack (TIA). (1.3) 1.1 Acute Coronary Syndrome or a History of Myocardial Infarction BRILINTA is indicated to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, it is superior to clopidogrel. BRILINTA also reduces the risk of stent thrombosis in patients who have been stented for treatment of ACS [see Clinical Studies (14.1) ] . 1.2 Coronary Artery Disease but No Prior Stroke or Myocardial Infarction BRILINTA is indicated to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events [see Clinical Studies (14.2) ] . While use is not limited to this setting, the efficacy of BRILINTA was established in a population with type 2 diabetes mellitus (T2DM). 1.3 Acute Ischemic Stroke or Transient Ischemic Attack (TIA) BRILINTA is indicated to reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score ≤5) or high-risk transient ischemic attack (TIA) [see Clinical Studies (14.3) ] .