Non-ST Elevation Acute Coronary Syndrome Clinical Trial
— NSTE-ACSOfficial title:
A Phase IV, Open Label Study, Comparing Ticagrelor Versus Clopidogrel in Non-ST Elevation Acute Coronary Syndrome (NSTE-ACS) Patients Undergoing Percutaneous Coronary Intervention (PCI) With Bivalirudin
| Verified date | June 2015 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The purpose of this study is to determine if ticagrelor is as effective as clopidogrel in rate of onset and degree of platelet inhibition for patients with non-ST elevation of acute coronary syndrome undergoing ad hoc PCI with bivalirudin.
| Status | Terminated |
| Enrollment | 34 |
| Est. completion date | April 2015 |
| Est. primary completion date | April 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Hospitalised for chest pain and potential acute coronary syndrome. - Onset of the most recent cardiac ischemic symptoms must occur within 7 days before randomisation and documented by cardiac ischemic symptoms of = 10 min duration at rest and at least 2 of the following: ST segment changes on ECG indicative of ischemia, or Positive biomarker evdience of myocardial necrosis, or other risk factors such as: 60 yrs of age or older, previous myocardial infarction or coronary bypass surgery, multi-vessel coronary artery disease, diabetes mellitus, peripheral arterial disease, chronic renal disfunction. - Females must be either surgically sterile or post-menopausal. - ACT </= 300 at the time of study treatment Exclusion Criteria: - Participation in another clinical study with an investigational product during the last 30 days. - Current acute complication of percutaneous coronary intervention or coronary bypass surgery. - Any contraindication to ticagrelor, clopidogrel or bivalirudin. - ST elevation myocardial infraction within 24 hours of study entry. - Any indications for oral anticoagulation or aspirin dose other than 75 to 100 mg daily. - Planned use of omeprazole or esomeprazole. - Patients with known bleeding or coagulation disorders; patients requiring dialysis; patients who have an inability to swallow medication. - Patients with known bleeding diathesis or coagulation disorder; history of intracranial bleed. - Use of IV heparin less than 2 hours before procedure. - Sustained uncontrolled high blood pressure |
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Research Site | Hershey | Pennsylvania |
| United States | Research Site | Jacksonville | Florida |
| United States | Research Site | Lake Mary | Florida |
| United States | Research Site | Macon | Georgia |
| United States | Research Site | Oklahoma City | Oklahoma |
| United States | Research Site | Philadelphia | Pennsylvania |
| United States | Research Site | Pittsburgh | Pennsylvania |
| United States | Research Site | Rapid City | South Dakota |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Change in the activated clotting time (ACT) of blood | On day of PCI procedure, the degree of anticoagulation response will be measured using the Hemochron ACT clot detection module to measure the length of time required for blood clot formation. The blood samples will be tested at each time point specified. | Pre-dose, 5 minutes after bivalirudin bolus, at time of bivalirudin discontinuation, 1 hr and 2 hrs post bivalirudin discontinuation. | No |
| Other | Safety and tolerability of ticagrelor in terms of adverse events. | Adverse events of major bleeding | Visit 1 (Screening Day -7 to Day 1); Visit 2 (Randomization Day 1) and the Follow up telephone contact (4-7 days after randomization) | Yes |
| Primary | Change in inhibition of platelet aggregation and reactivity | On day of PCI procedure, blood samples will be tested using VerifyNow™ which measures platelet aggregation of whole blood and reports results in P2Y12 Reaction Units (PRU). The blood samples will be collected and tested at each time point specified. | 0.5 hour and 1 hour after single loading dose of ticagrelor or clopidogrel given at the time of the bivalirudin bolus | No |
| Secondary | Change in inhibition of platelet aggregation and reactivity | On day of PCI procedure, blood samples will be tested using Verify Now™ which measures platelet aggregation of whole blood and reports results in P2Y12 Reaction Units (PRU). The blood samples will be collected and tested at Baseline and at each time point specified. | 2 hrs, 3 hrs, and 4 hours after single loading dose of ticagrelor or clopidogrel given at the time of the bivalirudin bolus. | No |