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| Name | Class |
|---|---|
| Beijing Anzhen Hospital | OTHER |
| The First Affiliated Hospital of Dalian Medical University | OTHER |
| The Central Hospital of Jia Mu Si City | UNKNOWN |
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Guideline recommendations on the use of dual antiplatelet therapy have been formulated that ticagrelor 90 mg twice daily plus aspirin in preference to clopidogrel 75mg daily plus aspirin for ACS patients. Recent study found that ticagrelor 90mg twice a day orally could significantly reduce the occurrence of clopidogrel resistance and adverse cardiovascular events. The previous studies have reported that half-dose ticagrelor had the similar inhibitory effect on platelet aggregation as the standard-dose ticagrelor, which was significantly stronger than that in the clopidogrel group. One-quarter standard-dose ticagrelor provided greater degree of platelet inhibition than standard dose clopidogrel in Chinese patients with stable CAD. But large-scale clinical trials are still needed to confirm the effects of low-dose ticagrelor on platelet function in Chinese patients with coronary heart disease.
Dual Antiplatelet Therapy (DAPT) with aspirin and P2Y12 receptor inhibitor remains a cornerstone in the secondary prevention of coronary artery disease (CAD). Clopidogrel is one of the most commonly used antithrombotic agent that inhibits the platelet P2Y(12) adenosine diphosphate (ADP) receptor.
Ticagrelor is an oral, reversibly-binding, direct-acting P2Y12 receptor antagonist used clinically for the prevention of atherothrombotic events in patients with acute coronary syndromes (ACS). Guideline recommendations on the use of dual antiplatelet therapy have been formulated that ticagrelor 90 mg twice daily plus aspirin in preference to clopidogrel 75mg daily plus aspirin for ACS patients. Recent study found that ticagrelor 90mg twice a day orally could significantly reduce the occurrence of clopidogrel resistance and adverse cardiovascular events. The previous studies have reported that half-dose ticagrelor had the similar inhibitory effect on platelet aggregation as the standard-dose ticagrelor, which was significantly stronger than that in the clopidogrel group. One-quarter standard-dose ticagrelor provided greater degree of platelet inhibition than standard dose clopidogrel in Chinese patients with stable CAD. But large-scale clinical trials are still needed to confirm the effects of low-dose ticagrelor on platelet function in Chinese patients with coronary heart disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ticagrelor 45mg bidpo. | Experimental | To observe the efficacy and safety of ticagrelor 45mg bidpo. in patients with coronary artery disease. |
|
| ticagrelor 90mg qdpo. | Experimental | To observe the efficacy and safety of ticagrelor 90mg qdpo. in patients with coronary artery disease. |
|
| ticagrelor 90mg bidpo. | Active Comparator | To observe the efficacy and safety of ticagrelor 90mg bidpo. in patients with coronary artery disease. |
|
| clopidogrel 75mg qdpo. | Active Comparator | To observe the efficacy and safety of clopidogrel 75mg qdpo. in patients with coronary artery disease. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ticagrelor | Drug | ticagrelor 45 mg twice daily for 5 consecutive days at least. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| ADP-induced Inhibition of Platelet Aggregation | The venous blood samples for platelet function test were drawn after an overnight fast, at 12 hours post-last study-drug dose for subjects receiving twice-daily administrations, and at 24 hours post-last study-drug dose for subjects treated with once-daily regimens. The blood was collected in an evacuated vacuum tube containing 3.2% trisodium citrate and lithium heparin. Then the samples were processed within two hours of blood draw according to standard operating procedure. The physical properties of samples were analyzed using Thromboelastography (TEG) Hemostasis Analyzer (CFMS LEPU-8800, Lepu Medical Technology Co., Ltd, Beijing, China) and automated analytical software. TEG test used four channels to detect the effects of anti-platelet therapy via the arachidonic acid (AA) and ADP pathways. TEG test results were expressed in terms of ADP-induced inhibition of platelet aggregation (IPA, range 0% - 100%), with higher values indicating greater platelet inhibition. | up to 5 days |
| Number of Participants With Bleeding (Major or Minor Bleeding) | Major bleeding was defined as type ≥ 3 and minor bleeding as types 1 and 2, in accordance to the Bleeding Academic Research Consortium classification. (Mehran R et al. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449.) | up to 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| ADP-induced Platelet-fibrin Clot Strength (MA) | The physical properties of samples were analyzed using Thromboelastography (TEG) Hemostasis Analyzer (CFMS LEPU-8800, Lepu Medical Technology Co., Ltd, Beijing, China) and automated analytical software. TEG test used four channels to detect the effects of anti-platelet therapy via the arachidonic acid (AA) and ADP pathways. TEG test results were expressed in terms of ADP-induced platelet-fibrin clot strength (MA). A MA>47mm was shown to have a high predictive value for 3-year post-PCI ischemic events during dual antiplatelet therapy. Moreover, ROC curve and quartile analysis suggested MA<31 mm as a predictive value for post-PCI bleeding events (J Am Coll Cardiol. 2013;62(24):2261-73. doi: 10.1016/j.jacc.2013.07.101.). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yue Li, MD | Cardiovascular Department, the First Affiliated Hospital of Harbin Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thromboela-Stogram | Beijing | 100001 | China |
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3,737 CAD patients who received either clopidogrel or ticagrelor therapy and underwent TEG test from 11 medical centers. Among these patients, 1,725 subjects were treated with clopidogrel and 2,012 subjects were treated with different ticagrelor regimens.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ticagrelor 45mg Bidpo. | To observe the efficacy and safety of ticagrelor 45mg bidpo. in patients with coronary artery disease. Ticagrelor: ticagrelor 45 mg twice daily for 5 consecutive days at least. |
| FG001 | Ticagrelor 90mg Bidpo. | To observe the efficacy and safety of ticagrelor 90mg bidpo. in patients with coronary artery disease. ticagrelor: ticagrelor 90 mg twice daily for 5 consecutive days at least. |
| FG002 | Clopidogrel 75mg Qdpo. | To observe the efficacy and safety of clopidogrel 75mg qdpo. in patients with coronary artery disease. clopidogrel: clopidogrel 75 mg once daily for 5 consecutive days at least. |
| FG003 | Ticagrelor 90mg Qdpo. | To observe the efficacy and safety of ticagrelor 90mg qdpo. in patients with coronary artery disease. Ticagrelor: ticagrelor 90 mg once daily for 5 consecutive days at least. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Clopidogrel 75mg Qdpo. | To observe the efficacy and safety of clopidogrel 75mg qdpo. in patients with coronary artery disease. clopidogrel: clopidogrel 75 mg once daily for 5 consecutive days at least. |
| BG001 | Ticagrelor 90mg Bidpo. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | ADP-induced Inhibition of Platelet Aggregation | The venous blood samples for platelet function test were drawn after an overnight fast, at 12 hours post-last study-drug dose for subjects receiving twice-daily administrations, and at 24 hours post-last study-drug dose for subjects treated with once-daily regimens. The blood was collected in an evacuated vacuum tube containing 3.2% trisodium citrate and lithium heparin. Then the samples were processed within two hours of blood draw according to standard operating procedure. The physical properties of samples were analyzed using Thromboelastography (TEG) Hemostasis Analyzer (CFMS LEPU-8800, Lepu Medical Technology Co., Ltd, Beijing, China) and automated analytical software. TEG test used four channels to detect the effects of anti-platelet therapy via the arachidonic acid (AA) and ADP pathways. TEG test results were expressed in terms of ADP-induced inhibition of platelet aggregation (IPA, range 0% - 100%), with higher values indicating greater platelet inhibition. | Posted | Median | Inter-Quartile Range | percentage of inhibition of platelet agg | up to 5 days |
|
up to 5 days
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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 | Clopidogrel 75mg Qdpo. | To observe the efficacy and safety of clopidogrel 75mg qdpo. in patients with coronary artery disease. clopidogrel: clopidogrel 75 mg once daily for 5 consecutive days at least. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yue Li | Department of Cardiology, the First Affiliated Hospital, Harbin Medical University, Harbin, China | 86-451-85555673 | ly99ly@vip.163.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 16, 2019 | Aug 19, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Not provided
| ID | Term |
|---|---|
| D000077486 | Ticagrelor |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| First Affiliated Hospital of Kunming Medical University |
| OTHER |
| RenJi Hospital | OTHER |
| Tianjin Medical University General Hospital | OTHER |
| Weifang People's Hospital | OTHER |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | OTHER |
| Shengjing Hospital | OTHER |
| Shaanxi Provincial People's Hospital | OTHER |
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| ticagrelor |
| Drug |
ticagrelor 90 mg once daily for 5 consecutive days at least. |
|
| ticagrelor | Drug | ticagrelor 90 mg twice daily for 5 consecutive days at least. |
|
| clopidogrel | Drug | clopidogrel 75 mg once daily for 5 consecutive days at least. |
|
| up to 5 days |
| Number of Participants With High On-Treatment Platelet Reactivity (HTPR) | HTPR was defined as IPA ≤ 30% and MA ≥ 47 mm. | up to 5 days |
| Number of Participants With Cardiovascular Event (Cardiovascular Death, New-onset Myocardial Infarction, or Stroke) | Cardiovascular death was defined as sudden cardiac death, fatal myocardial infarction, death due to heart failure, or death due to other cardiovascular causes. Stroke was defined as the focal loss of neurologic function caused by an ischemic or a hemorrhagic event with residual symptoms lasting at least 24 hours or eventually leading to death. | up to 5 days |
| Number of Participants With New-onset Dyspnea | New-onset dyspnea in patients without previous history of dyspnea | up to 5 days |
To observe the efficacy and safety of ticagrelor 90mg bidpo. in patients with coronary artery disease. ticagrelor: ticagrelor 90 mg twice daily for 5 consecutive days at least. |
| BG002 | Ticagrelor 45mg Bidpo. | To observe the efficacy and safety of ticagrelor 45mg bidpo. in patients with coronary artery disease. Ticagrelor: ticagrelor 45 mg twice daily for 5 consecutive days at least. |
| BG003 | Ticagrelor 90mg Qdpo. | To observe the efficacy and safety of ticagrelor 90mg qdpo. in patients with coronary artery disease. ticagrelor: ticagrelor 90 mg once daily for 5 consecutive days at least. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Median | Inter-Quartile Range | kg |
|
| smoking | Count of Participants | Participants |
|
| Hypertension | Count of Participants | Participants |
|
| diabetes mellitus | Count of Participants | Participants |
|
| chronic kidney disease | Count of Participants | Participants |
|
| percutaneous coronary intervention | Count of Participants | Participants |
|
| coronary artery bypass grafting | Count of Participants | Participants |
|
| total cholesterol | Median | Inter-Quartile Range | mmol/L |
|
| triglyceride | Median | Inter-Quartile Range | mmol/L |
|
| high density lipoprotein | Median | Inter-Quartile Range | mmol/L |
|
| low density lipoprotein | Median | Inter-Quartile Range | mmol/L |
|
| creatinine | Median | Inter-Quartile Range | μmol/L |
|
| uric acid | Median | Inter-Quartile Range | μmol/L |
|
| aspirin use | Count of Participants | Participants |
|
| acute myocardial infarction | Count of Participants | Participants |
|
| OG000 |
| Clopidogrel 75mg Qdpo. |
To observe the efficacy and safety of clopidogrel 75mg qdpo. in patients with coronary artery disease. clopidogrel: clopidogrel 75 mg once daily for 5 consecutive days at least. |
| OG001 | Ticagrelor 90mg Bidpo. | To observe the efficacy and safety of ticagrelor 90mg bidpo. in patients with coronary artery disease. ticagrelor: ticagrelor 90 mg twice daily for 5 consecutive days at least. |
| OG002 | Ticagrelor 45mg Bidpo. | To observe the efficacy and safety of ticagrelor 45mg bidpo. in patients with coronary artery disease. Ticagrelor: ticagrelor 45 mg twice daily for 5 consecutive days at least. |
| OG003 | Ticagrelor 90mg Qdpo. | To observe the efficacy and safety of ticagrelor 90mg qdpo. in patients with coronary artery disease. ticagrelor: ticagrelor 90 mg once daily for 5 consecutive days at least. |
|
|
| Primary | Number of Participants With Bleeding (Major or Minor Bleeding) | Major bleeding was defined as type ≥ 3 and minor bleeding as types 1 and 2, in accordance to the Bleeding Academic Research Consortium classification. (Mehran R et al. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449.) | Posted | Count of Participants | Participants | up to 5 days |
|
|
|
| Secondary | ADP-induced Platelet-fibrin Clot Strength (MA) | The physical properties of samples were analyzed using Thromboelastography (TEG) Hemostasis Analyzer (CFMS LEPU-8800, Lepu Medical Technology Co., Ltd, Beijing, China) and automated analytical software. TEG test used four channels to detect the effects of anti-platelet therapy via the arachidonic acid (AA) and ADP pathways. TEG test results were expressed in terms of ADP-induced platelet-fibrin clot strength (MA). A MA>47mm was shown to have a high predictive value for 3-year post-PCI ischemic events during dual antiplatelet therapy. Moreover, ROC curve and quartile analysis suggested MA<31 mm as a predictive value for post-PCI bleeding events (J Am Coll Cardiol. 2013;62(24):2261-73. doi: 10.1016/j.jacc.2013.07.101.). | Posted | Median | Inter-Quartile Range | mm | up to 5 days |
|
|
|
| Secondary | Number of Participants With High On-Treatment Platelet Reactivity (HTPR) | HTPR was defined as IPA ≤ 30% and MA ≥ 47 mm. | Posted | Count of Participants | Participants | up to 5 days |
|
|
|
| Secondary | Number of Participants With Cardiovascular Event (Cardiovascular Death, New-onset Myocardial Infarction, or Stroke) | Cardiovascular death was defined as sudden cardiac death, fatal myocardial infarction, death due to heart failure, or death due to other cardiovascular causes. Stroke was defined as the focal loss of neurologic function caused by an ischemic or a hemorrhagic event with residual symptoms lasting at least 24 hours or eventually leading to death. | Posted | Count of Participants | Participants | up to 5 days |
|
|
|
| Secondary | Number of Participants With New-onset Dyspnea | New-onset dyspnea in patients without previous history of dyspnea | Posted | Count of Participants | Participants | up to 5 days |
|
|
|
| 0 |
| 1,511 |
| 0 |
| 1,511 |
| 0 |
| 1,511 |
| EG001 | Ticagrelor 90mg Bidpo. | To observe the efficacy and safety of ticagrelor 90mg bidpo. in patients with coronary artery disease. ticagrelor: ticagrelor 90 mg twice daily for 5 consecutive days at least. | 0 | 501 | 0 | 501 | 0 | 501 |
| EG002 | Ticagrelor 45mg Bidpo. | To observe the efficacy and safety of ticagrelor 45mg bidpo. in patients with coronary artery disease. Ticagrelor: ticagrelor 45 mg twice daily for 5 consecutive days at least. | 0 | 525 | 0 | 525 | 0 | 525 |
| EG003 | Ticagrelor 90mg Qdpo. | To observe the efficacy and safety of ticagrelor 90mg qdpo. in patients with coronary artery disease. ticagrelor: ticagrelor 90 mg once daily for 5 consecutive days at least. | 0 | 506 | 0 | 506 | 0 | 506 |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| 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 |
| Major bleeding |
|
| No bleeding |
|
| Non-HTPR |
|
| Participants without cardiovascular events |
|
| Participants with new-onset myocardial infarction |
|
| Participants with stroke |
|
| Participants without new-onset dyspne |
|