Current partner codePEPTIDESDE
NCT02052635·Phase 4·INTERVENTIONAL

Ticagrelor vs Clopidogrel in Non-ST Elevation Acute Coronary Syndrome Patients Undergoing PCI With Bivalirudin.

Status

Terminated

Phase

Phase 4

Enrollment

34

Locations

8

Results

Posted

Publications

0

Study summary

What the protocol is testing.

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 (NSTE-ACS) undergoing ad hoc percutaneous coronary intervention (PCI) with bivalirudin.

Full detailed description

Multi-center, open-label study that will compare the onset of the platelet inhibition with ticagrelor versus clopidogrel when administered with bivalirudin during PCI on a background therapy of aspirin in patients with NSTE-ACS.

Interventions

Treatment arms and agents.

DRUG

ticagrelor

Single loading dose of 180mg of ticagrelor at time of bivalirudin administration. Beginning 12 hrs following study drug administration, all pts in the ticagrelor arm will receive ticagrelor 90 mg (maintenance dose) approximately every 12 hrs until Follow-up telephone contact.

DRUG

clopidogrel

Single loading oral dose of 600 mg of clopidogrel will be given at time of bivalirudin administration. Beginning 4 hrs following study drug administration, all pts in the clopidorgrel arm will receive ticagrelor 180 mg for the loading dose, followed by 90 mg maintenance dose approximately every 12 hours until the Follow-up telephone contact.

Timeline

From registration to results.

  1. First posted

    Feb 3, 2014

  2. Study start

    Sep 2014

  3. Primary completion

    Apr 2015

  4. Study completion

    Apr 2015

  5. Results posted

    Apr 6, 2016

  6. Registry updated

    May 27, 2016

Outcomes

What the study measures.

Primary outcomes

P2Y12 Reaction Units (PRU) Using VerifyNow™ at 0.5 Hours After Loading Dose

Time frame · 0.5 hours post loading dose

PRU at 0.5 hours after a single oral loading dose of either ticagrelor 180 mg or clopidogrel 600 mg given at the time of the bivalirudin bolus

P2Y12 Reaction Units (PRU) Using VerifyNow™ at 1 Hour After Loading Dose

Time frame · 1 hour post loading dose

PRU at 1 hour after a single oral loading dose of either ticagrelor 180 mg or clopidogrel 600 mg given at the time of the bivalirudin bolus

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
130 Years
Sex
ALL
Healthy volunteers
No

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 electrocardiogram (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. * Activated Clotting Time (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 milligrams (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 Intravenous (IV) heparin less than 2 hours before procedure. * Sustained uncontrolled high blood pressure

Study locations

8 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

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

Hershey, Pennsylvania, United States

Research Site

Philadelphia, Pennsylvania, United States

Research Site

Pittsburgh, Pennsylvania, United States

Research Site

Rapid City, South Dakota, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Bivalirudin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.