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The purpose of this study is to test the hypothesis that the onset of the antiplatelet effect of ticagrelor is more rapid and greater than clopidogrel in Chinese patients with ACS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ticagrelor | Experimental |
| |
| clopidogrel | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ticagrelor | Drug | 90mg tablets. loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. Duration of treatment: 6 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| the Percentage Inhibition of the P2Y12 Receptor | Note: the primary endpoint was changed per the statistical analysis plan prior database lock. | at 2 hours after first dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| the Percentage Inhibition of the P2Y12 Receptor | at 0.5 hour after first dose of study drug | |
| the Percentage Inhibition of the P2Y12 Receptor | at 8 hours after first dose of study drug | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yundai Chen, Professor | The General Hospital of People's Liberation Army | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Beijing | China | ||||
| Research Site |
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| Label | URL |
|---|---|
| D5130L00053\_CSR\_Synopsis | View source |
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There was no run-in or any other pre-assignment periods following participant enrollment.
First subject enrolled: 15/05/2013, Last subject last visit: 18/03/2014. There were 5 study centers in China, which participated this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ticagrelor | Patients received a loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. The third dose of ticagrelor was given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 90mg of ticagrelor orally bd. The total study period was 6 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Clopidogrel | Drug | 75mg capsule. loading dose of 600mg clopidogrel capsules (eight 75mg capsules) taken orally, follow by 75mg of clopidogrel capsules orally od. Duration of treatment: 6 weeks. |
|
| the Percentage Inhibition of the P2Y12 Receptor |
| at 24 hours after first dose of study drug |
| the Percentage Inhibition of the P2Y12 Receptor | at 6 weeks after first dose of study drug |
| Shenyang |
| China |
| Research Site | Tianjin | China |
| FG001 | Clopidogrel | Patients received a loading dose of 600mg clopidogrel tablets (eight 75mg tablets) taken orally. The second dose of clopidogrel had been given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 75mg of clopidogrel orally od. The total study period was 6 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Three randomized patients were excluded from the full analysis set (FAS) due to any of the following reasons: 1) did not meet exclusion requirments but was randomized, 2)post-treatment blood PRU was not available, 3) pre-treatment blood PRU was missing, and 4) use of prohibited medications.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ticagrelor | Patients received a loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. The third dose of ticagrelor was given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 90mg of ticagrelor orally bd. The total study period was 6 weeks. |
| BG001 | Clopidogrel | Patients received a loading dose of 600mg clopidogrel tablets (eight 75mg tablets) taken orally. The second dose of clopidogrel had been given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 75mg of clopidogrel orally od. The total study period was 6 weeks. |
| 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 |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | 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 | the Percentage Inhibition of the P2Y12 Receptor | Note: the primary endpoint was changed per the statistical analysis plan prior database lock. | FAS (full analysis set). Three randomized patients were excluded from FAS due to any of the following reasons: 1) did not meet exclusion requirments but was randomized, 2)post-treatment blood PRU was not available, 3) pre-treatment blood PRU was missing, and 4) use of prohibited medications. | Posted | Mean | Standard Deviation | Percentage Inhibition | at 2 hours after first dose of study drug |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | the Percentage Inhibition of the P2Y12 Receptor | PPS (per-protocol set). Seven randomized patients were excluded from PPS due to any of the following reasons: 1) did not meet exclusion requirments but was randomized, 2)post-treatment blood PRU was not available, 3) pre-treatment blood PRU was missing, 4) missing blood PRU at 2h after first dose, and 5) use of prohibited medications. | Posted | Mean | Standard Deviation | Percentage Inhibition | at 0.5 hour after first dose of study drug |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | the Percentage Inhibition of the P2Y12 Receptor | PPS (per-protocol set). Seven randomized patients were excluded from PPS due to any of the following reasons: 1) did not meet exclusion requirments but was randomized, 2)post-treatment blood PRU was not available, 3) pre-treatment blood PRU was missing, 4) missing blood PRU at 2h after first dose, and 5) use of prohibited medications. | Posted | Mean | Standard Deviation | Percentage Inhibition | at 8 hours after first dose of study drug |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | the Percentage Inhibition of the P2Y12 Receptor | PPS (per-protocol set). Seven randomized patients were excluded from PPS due to any of the following reasons: 1) did not meet exclusion requirments but was randomized, 2)post-treatment blood PRU was not available, 3) pre-treatment blood PRU was missing, 4) missing blood PRU at 2h after first dose, and 5) use of prohibited medications. | Posted | Mean | Standard Deviation | Percentage Inhibition | at 24 hours after first dose of study drug |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | the Percentage Inhibition of the P2Y12 Receptor | PPS (per-protocol set). Seven randomized patients were excluded from PPS due to any of the following reasons: 1) did not meet exclusion requirments but was randomized, 2)post-treatment blood PRU was not available, 3) pre-treatment blood PRU was missing, 4) missing blood PRU at 2h after first dose, and 5) use of prohibited medications. | Posted | Mean | Standard Deviation | Percentage Inhibition | at 6 weeks after first dose of study drug |
|
|
6 weeks for all AEs and another 14 days for SAEs.
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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 | Patients received a loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. The third dose of ticagrelor was given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 90mg of ticagrelor orally bd. The total study period was 6 weeks. | 1 | 29 | 12 | 29 | ||
| EG001 | Clopidogrel | Patients received a loading dose of 600mg clopidogrel tablets (eight 75mg tablets) taken orally. The second dose of clopidogrel had been given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 75mg of clopidogrel orally od. The total study period was 6 weeks. | 1 | 31 | 12 | 31 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 16.1 |
| ||
| Drug-induced liver injury | Injury, poisoning and procedural complications | MedDRA 16.1 |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertensive heart disease | Cardiac disorders | MedDRA 16.1 |
| ||
| Arrhythmia | Cardiac disorders | MedDRA 16.1 |
| ||
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 16.1 |
| ||
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 16.1 |
| ||
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 16.1 |
| ||
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 16.1 |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 |
| ||
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.1 |
| ||
| Atrial fibrillation | Cardiac disorders | MedDRA 16.1 |
| ||
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 16.1 |
| ||
| Constipation | Gastrointestinal disorders | MedDRA 16.1 |
| ||
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 |
| ||
| Toothache | Gastrointestinal disorders | MedDRA 16.1 |
| ||
| Lung infection | Infections and infestations | MedDRA 16.1 |
| ||
| Orchitis | Infections and infestations | MedDRA 16.1 |
| ||
| Pharyngitis | Infections and infestations | MedDRA 16.1 |
| ||
| Postoperative wound infection | Infections and infestations | MedDRA 16.1 |
| ||
| Puncture site infection | Infections and infestations | MedDRA 16.1 |
| ||
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.1 |
| ||
| Blood creatine increased | Investigations | MedDRA 16.1 |
| ||
| Blood creatinine increased | Investigations | MedDRA 16.1 |
| ||
| Blood triglycerides increased | Investigations | MedDRA 16.1 |
| ||
| Hypoglycemia | Metabolism and nutrition disorders | MedDRA 16.1 |
| ||
| Metabolic disorder | Metabolism and nutrition disorders | MedDRA 16.1 |
| ||
| Headache | Nervous system disorders | MedDRA 16.1 |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 |
| ||
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 |
| ||
| Skin haemorrhage | Skin and subcutaneous tissue disorders | MedDRA 16.1 |
| ||
| Ecchymosis | Vascular disorders | MedDRA 16.1 |
| ||
| Haematoma | Vascular disorders | MedDRA 16.1 |
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| Hypertension | Vascular disorders | MedDRA 16.1 |
| ||
| Hypotension | Vascular disorders | MedDRA 16.1 |
|
(1) Sample size was relatively small. (2) Study duration with 6 weeks seemed limited. (3) Sampling time-points seemed relatively scarce, such as missing the time point for 1-hour and 4-hour after loading dose.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Judith Hsia | Astrazeneca | 1-301-398-0102 | judithhsia@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 |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 0.0003 |
| Mean Difference (Final Values) |
| 38.421 |
| 2-Sided |
| 95 |
| 18.559 |
| 58.283 |
| No |
| Superiority or Other |
| Counts |
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| Participants |
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| Counts |
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| Participants |
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| Counts |
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| Participants |
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| Counts |
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| Participants |
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