Official Title

Pharmacodynamic Evaluation of Antiplatelet Effect of Swallowing Versus Chewing Ticagrelor in Patients With Acute Coronary Syndrome
  • Phase

    Phase 4
  • Study Type

    Interventional
  • Status

    Unknown status
  • Study Participants

    50
The study aims to determine the pharmacodynamic performance in the first hour measured with verifynow, of the conventional ticagrelor loaded dose versus chewed ticagrelor in patients with acute coronary syndrome treated with percutaneous coronary intervention
Study Started
Oct 07
2020
Primary Completion
Aug 15
2021
Anticipated
Study Completion
Sep 30
2021
Anticipated
Last Update
Jul 29
2021

Drug Chewed ticagrelor

Chewed ticagrelor (Brilinta) 90 mg tablets, 2 tablets

Drug Swallowed ticagrelor

Swallowed ticagrelor (Brilinta) 90 mg tablets, 2 tablets

Chewed ticagrelor Experimental

Ticagrelor pills. The 180 mg loading dose will be administered as soon as possible by investigation staff after a baseline VerifyNow measurement and after signed informed consent. Patients will be asked to chew, but not to swallow, during at least 40 seconds in presence of investigation staff. Drug: ticagrelor (Brilinta) 90 mg tablets, 2 tablets chewed

Swallowed ticagrelor Active Comparator

Ticagrelor integral tablet. The 180 mg loading dose will be administered as soon as possible by investigation staff after a baseline VerifyNow measurement is drawn. Patients will swallow the loading dose followed by 25-40 ml of water. Drug: ticagrelor (Brilinta) 90 mg tableta, 2 tablets swallowed

Criteria

Inclusion Criteria:

All patients presenting to the emergency department with acute coronary syndrome for percutaneous coronary intervention

Exclusion Criteria:

Age <18 years
Known coagulopathy, bleeding diathesis, or active bleeding
History of recent gastrointestinal or genitourinary bleeding within 2 months
Previous therapy with clopidogrel, prasugrel, or ticagrelor
Previous treatment with glycoprotein IIb/IIIa inhibitors or during interventional procedure
Major surgery within 6 weeks
History of intracranial bleeding or intracraneal neoplasm
Suspected aortic dissection
Chronic obstructive pulmonary disease
Severe hemodynamic instability or cardiogenic shock
Resuscitated cardiac arrest
Use of vitamin K anticoagulants or novel oral anticoagulants (NOACs) within 7 days
Life expectancy <1 year
Known severe liver or renal disease, GFR estimated by CKD-EPI <30 ml/min/1.73 m2
Known HIV treatment
Hemoglobin <10 g/dL
Platelet count <100,000/L
Pregnancy
Known allergy to ticagrelor
Refusal to sign informed consent
No Results Posted