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

NCT02052635 | Terminated Phase 4 Results

• 1 other identifier: D5130L00065
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Non-ST Elevation Acute Coronary Syndrome

Keywords

Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (2)

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

  0.5 hours post loading dose

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

  1 hour post loading dose

Study Arms (2)

Ticagrelor

EXPERIMENTAL

90 mg oral tablet

Drug: ticagrelor

Clopidogrel

ACTIVE COMPARATOR

300 mg oral tablet

Drug: clopidogrel

Interventions

ticagrelor DRUG

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.

Also known as: Brilinta

Ticagrelor

clopidogrel DRUG

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.

Also known as: Plavix

Clopidogrel

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (8)

Research Site

Jacksonville, Florida, United States

Location

Research Site

Lake Mary, Florida, United States

Location

Research Site

Macon, Georgia, United States

Location

Research Site

Oklahoma City, Oklahoma, United States

Location

Research Site

Hershey, Pennsylvania, United States

Location

Research Site

Philadelphia, Pennsylvania, United States

Location

Research Site

Pittsburgh, Pennsylvania, United States

Location

Research Site

Rapid City, South Dakota, United States

Location

MeSH Terms

Interventions

Ticagrelor; Clopidogrel

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

The target sample size for this study was 100 patients. But due to recruitment challenges and low enrolment,the study was terminated early with only 13 pateints randomized. No formal statistical analyses were performed.

Results Point of Contact

• Title: Anders Himmelmann, MD PhD
• Organization: AstraZeneca AB

ClinicalTrialTransparency@astrazeneca.com

+46 31 7761000

Study Officials

• Marc Cohen, MD

  Newark Beth Israel Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2014
• First Posted: February 3, 2014
• Study Start: September 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: May 27, 2016
• Results First Posted: April 6, 2016

Record last verified: 2016-04

Locations

US (8)