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The purpose of this study is to assess the pharmacodynamic effect of ticagrelor in ACS patients undergoing an Ad Hoc PCI
A randomized, open-label, multiple-center, parallel group study to compare the platelet inhibition with VerifyNow assay of ticagrelor versus clopidogrel in troponin negative Acute Coronary Syndrome (ACS) subjects undergoing Ad Hoc percutaneous coronary intervention (PCI)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ticagrelor | Experimental | Ticagrelor - 180 mg loading dose |
|
| Clopidogrel | Active Comparator | Clopidogrel - 600 mg loading dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ticagrelor | Drug | 180 mg loading dose |
| |
| Clopidogrel |
| Measure | Description | Time Frame |
|---|---|---|
| Inhibition of the P2Y12 Receptor at 2 Hours After Loading Doses of Ticagrelor and Clopidogrel as Measured by P2Y12 Reaction Units (PRU) From VerifyNow™ | Participants with low (<150) baseline PRU values were excluded. | 2 hours after the loading dose |
| Measure | Description | Time Frame |
|---|---|---|
| Inhibition of the P2Y12 Receptor at 0.5 Hours, End of PCI, and 8 Hours After Loading Doses of Ticagrelor and Clopidogrel as Measured by PRU From VerifyNow™ | Participants with low (<150) baseline PRU values were excluded. | 0.5 hours, end of PCI, and 8 hours after the loading dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Glenn F. Carlson, MD | AstraZeneca Pharmaceuticals, Wilmington, DE 19850-5437 USA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Birmingham | Alabama | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28356282 | Derived | Sweeny JM, Angiolillo DJ, Franchi F, Rollini F, Waksman R, Raveendran G, Dangas G, Khan ND, Carlson GF, Zhao Y, Teng R, Mehran R. Impact of Diabetes Mellitus on the Pharmacodynamic Effects of Ticagrelor Versus Clopidogrel in Troponin-Negative Acute Coronary Syndrome Patients Undergoing Ad Hoc Percutaneous Coronary Intervention. J Am Heart Assoc. 2017 Mar 29;6(4):e005650. doi: 10.1161/JAHA.117.005650. | |
| 26868683 |
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Overall, 343 participants were screened; 102 met inclusion/exclusion criteria, 100 were randomized. 96 participants completed treatment and 97 participants completed the study.
Participants recruited from 15 actively participating sites in the United States of America, from July 2012 until June 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ticagrelor | 180 mg loading dose after diagnostic angiography, followed by 90 mg after 12 hours (± 1 hour), with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg) |
| FG001 | Clopidogrel |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
600 mg loading dose |
|
| San Francisco |
| California |
| United States |
| Research Site | Washington D.C. | District of Columbia | United States |
| Research Site | Jacksonville | Florida | United States |
| Research Site | Ypsilanti | Michigan | United States |
| Research Site | Minneapolis | Minnesota | United States |
| Research Site | Tupelo | Mississippi | United States |
| Research Site | North Kansas City | Missouri | United States |
| Research Site | Belleville | New Jersey | United States |
| Research Site | New York | New York | United States |
| Research Site | The Bronx | New York | United States |
| Research Site | Greensboro | North Carolina | United States |
| Research Site | Cincinnati | Ohio | United States |
| Research Site | Oklahoma City | Oklahoma | United States |
| Research Site | Tyler | Texas | United States |
| Research Site | Richmond | Virginia | United States |
| Derived |
| Angiolillo DJ, Franchi F, Waksman R, Sweeny JM, Raveendran G, Teng R, Zhao Y, Carlson G, Khan N, Mehran R. Effects of Ticagrelor Versus Clopidogrel in Troponin-Negative Patients With Low-Risk ACS Undergoing Ad Hoc PCI. J Am Coll Cardiol. 2016 Feb 16;67(6):603-613. doi: 10.1016/j.jacc.2015.11.044. |
600 mg loading dose after diagnostic angiography, with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg) |
| COMPLETED |
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| NOT COMPLETED |
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|
Randomized Analysis Set, defined as all participants who signed informed consent, who provided demographic and/or baseline screening assessments, and who were randomized into the study regardless of the participant's randomization and treatment status in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ticagrelor | 180 mg loading dose after diagnostic angiography, followed by 90 mg after 12 hours (± 1 hour), with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg) |
| BG001 | Clopidogrel | 600 mg loading dose after diagnostic angiography, with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg) |
| 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | Participants |
|
| 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 | Inhibition of the P2Y12 Receptor at 2 Hours After Loading Doses of Ticagrelor and Clopidogrel as Measured by P2Y12 Reaction Units (PRU) From VerifyNow™ | Participants with low (<150) baseline PRU values were excluded. | Pharmacodynamic (PD) Analysis Set (N=93; 46 on ticagrelor, 47 on clopidogrel) - included all participants with PD data and without a major protocol deviation thought to significantly affect the PD of ticagrelor or clopidogrel. Participants in the PD Analysis Set with low (<150) baseline PRU values were excluded from the analyses. | Posted | Mean | Standard Deviation | PRU | 2 hours after the loading dose |
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| Secondary | Inhibition of the P2Y12 Receptor at 0.5 Hours, End of PCI, and 8 Hours After Loading Doses of Ticagrelor and Clopidogrel as Measured by PRU From VerifyNow™ | Participants with low (<150) baseline PRU values were excluded. | PD Analysis Set. Participants in the PD Analysis Set with low (<150) baseline PRU values were excluded from the analyses. | Posted | Mean | Standard Deviation | PRU | 0.5 hours, end of PCI, and 8 hours after the loading dose |
|
|
All adverse events (AEs), including serious AEs were monitored from the point of informed consent through the 14 day follow up period. All vascular events were assessed at each visit and could be reported by participants at any time during the study.
AEs were solicited at each scheduled visit and could be reported by the participant at any time during the study.
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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 | 180 mg loading dose after diagnostic angiography, followed by 90 mg after 12 hours (± 1 hour), with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg) | 9 | 51 | 5 | 51 | ||
| EG001 | Clopidogrel | 600 mg loading dose after diagnostic angiography, with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg) | 5 | 49 | 1 | 49 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Duodenitis | Gastrointestinal disorders | MedDRA v17.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v17.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v17.0 | Systematic Assessment |
| |
| Lactic acidosis | Metabolism and nutrition disorders | MedDRA v17.0 | Systematic Assessment |
| |
| Grand mal convulsion | Nervous system disorders | MedDRA v17.0 | Systematic Assessment |
| |
| Partial seizures | Nervous system disorders | MedDRA v17.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v17.0 | Systematic Assessment |
| |
| Atrioventricular block second degree | Cardiac disorders | MedDRA v17.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA v17.0 | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA v17.0 | Systematic Assessment |
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| Angina unstable | Cardiac disorders | MedDRA v17.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA v17.0 | Systematic Assessment |
| |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA v17.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v17.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain | General disorders | MedDRA v17.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v17.0 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA v17.0 | Systematic Assessment |
|
An Investigator agrees to provide a copy of the publication to AstraZeneca (AZ) for review at least 60 days in advance of the submission for publication. The Investigators in the Multi-Center (MC) study agree to postpone MC publications until the earlier of the first AZ-authorized publication or up to 18 months from study completion at all sites.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tomas LG Andersson, MD, PhD | AstraZeneca | 1-800-236-9393 | ClinicalTrialTransparency@astrazeneca.com |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| 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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| >=65 years |
|
| Male |
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| Asian |
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| Black or African American |
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| White |
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| Missing values |
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| Not Hispanic or Latino |
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| Not Reported |
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| Missing values |
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