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Patient recruitment challenges, low enrolment, and a forecasted inability to complete the study in an acceptable timeframe
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ticagrelor | Experimental | 90 mg oral tablet |
|
| Clopidogrel | Active Comparator | 300 mg oral tablet |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Cohen, MD | Newark Beth Israel Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Jacksonville | Florida | United States | |||
| Research Site |
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This study was conducted in the USA. While 17 sites were activated, 9 sites enrolled patients, and only 7 sites successfully randomised patients. There were 34 patients screened, 21 screen failures and 13 randomised patients from 03 September 2014 and 20 April 2015. The study was terminated due to recruitment challenges and low enrolment concerns.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ticagrelor | A single oral dose of 180 mg (90 mg tablet x2) of ticagrelor was administered at the time of the initial bivalirudin bolus administration. |
| FG001 | Clopidogrel | A single oral dose of 600 mg (300 mg tablet x2) of clopidogrel was administered at the time of the initial bivalirudin bolus administration. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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. |
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| 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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ticagrelor | A single oral dose of 180 mg (90 mg tablet x2) of ticagrelor was administered at the time of the initial bivalirudin bolus administration. |
| BG001 | Clopidogrel | A single oral dose of 600 mg (300 mg tablet x2) of clopidogrel was administered at the time of the initial bivalirudin bolus administration. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 10 patients were included in the pharmacodynamic (PD) analysis: 6 patients in the ticagrelor group and 4 patients in the clopidogrel group. 3 out 13 randomized pateints are excluded (1 patient without any PRU data, 2 pateints with protocol deviations) | Posted | Mean | Standard Deviation | PRUs | 0.5 hours post loading dose |
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| Primary | 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 | 10 patients were included in the PD analysis: 6 patients in the ticagrelor group and 4 patients in the clopidogrel group. Out of the 10 patients in the PD analysis, 1 patient in Ticagrelor group does not have PRU value at 1 hour post loading dose. | Posted | Mean | Standard Deviation | PRUs | 1 hour post loading dose |
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Serious adverse events (SAEs) from informed consent to follow-up contact (4-7 days after treatment) and non-serious adverse events (AEs) of interest from time of randomisation to follow-up. All SAEs and non-serious AEs of interest will be recorded.
This study just collects the following non-serious AEs of interest: bleeding events, dyspnoea, renal impairment/increased creatinine, brady arrhythmic event, increased liver function tests, gout/uric acid increases, pneumonia, gynecomastia, abnormal uterine bleeding, all malignancies excluding non-melanoma skin cancers.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ticagrelor | A single oral dose of 180 mg (90 mg tablet x2) of ticagrelor was administered at the time of the initial bivalirudin bolus administration. | 0 | 7 | 2 | 7 | ||
| EG001 | Clopidogrel | A single oral dose of 600 mg (300 mg tablet x2) of clopidogrel was administered at the time of the initial bivalirudin bolus administration. | 0 | 6 | 2 | 6 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery perforation | Cardiac disorders | MedDRA V17.0 | Systematic Assessment |
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| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA V17.0 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA V17.0 | Systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA V17.0 | Systematic Assessment |
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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.
The PI shall provide the Sponsor with copies of any materials at least thirty days in advance of publication, submission or presentation. At the request of the Sponsor, the PI shall withhold publication, submission for publication or presentation for a period of ninety days from the date on which the Sponsor receives the material to allow the Sponsor to take such measures as the Sponsor considers necessary to preserve its proprietary rights and/or protect its Confidential Information.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anders Himmelmann, MD PhD | AstraZeneca AB | +46 31 7761000 | ClinicalTrialTransparency@astrazeneca.com |
| ID | Term |
|---|---|
| D000077486 | Ticagrelor |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Male |
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