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A multicenter, single arm, open label, Phase IV study to evaluate safety and to describe the cumulative incidence of major cardiovascular events of Ticagrelor in Taiwanese patients with non ST-segment (a segment in the eletrocardiogram which presents the period when ventricles are depolarized) elevation myocardial infarction
This study will be conducted in approximately 8 investigational centres in Taiwan. It is expected that approximately 100 patients will be enrolled into study treatment. This study is to describe the safety and tolerability of ticagrelor, by assessment of the bleeding events and other serious adverse events (SAEs) during 1year follow up in Taiwanese non ST-elevation myocardial infarction (NSTEMI) patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single arm | Experimental | Ticagrelor 180mg loading dose taken orally, followed by 90mg twice daily (bd) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ticagrelor 180mg loading dose taken orally, followed by 90mg twice daily (bd) | Drug | Ticagrelor 180mg loading dose taken orally, followed by 90mg twice daily (bd) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Fatal/Life-threatening Bleedings | Evaluation of PLATO (PLATelet inhibition and patient Outcomes)-defined fatal/life-threatening bleedings | during 1year follow up with ticagrelor treatment |
| Number of Participants With Bleeding Events (Major Bleedings) | Evaluation of PLATO (PLATelet inhibition and patient Outcomes)-defined major bleedings | during 1year follow up with ticagrelor treatment |
| Number of Participants With Bleeding Events (Major and Minor Bleedings) | Evaluation of PLATO (PLATelet inhibition and patient Outcomes)-defined major + minor bleedings | during 1year follow up with ticagrelor treatment |
| Number of Participants With Other Serious Adverse Event (SAEs) | Evaluation of serious adverse events other than bleedings | during 1year follow up with ticagrelor treatment |
| Number of Participants With Major Cardiovascular Events | Evaluation of major cardiovascular events including cardiovascular death, myocardial infarction or stroke | during 1year follow up with ticagrelor treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chun-peng Liu, Ph.D | Kaohsiung Veterans General Hospital. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Changhua | 50006 | Taiwan | |||
| Research Site |
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| Label | URL |
|---|---|
| RevisedCSP2D5130C00103Redacted\_a | View source |
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Out of the patients who provided informed consent 95.6 % (n=108) of the patients received study drug. 8 patients provided informed consent but did not fulfill eligibility criteria, out of whom 5 did not receive treatment and 3 received treatment.
This study was conducted at 13 centres in Taiwan. The first patient was enrolled on 23 April 2015 and the last visit of the last patient took was on 9 February 2017. Informed consent was received for 113 patients
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm | Ticagrelor 90mg twice daily (bd) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm | Ticagrelor 90mg twice daily (bd) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants With Fatal/Life-threatening Bleedings | Evaluation of PLATO (PLATelet inhibition and patient Outcomes)-defined fatal/life-threatening bleedings | Posted | Count of Participants | Participants | during 1year follow up with ticagrelor treatment |
|
|
On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 1year if the participant completed treatment according to the study plan. All-cause mortality is collected during 1 year follow-up, including deaths that occur more than 7 days after last dose.
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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 | Single Arm | Ticagrelor 90mg twice daily (bd) | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA version 19.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA version 19.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brilinta Global Clinical Lead | AstraZeneca R&D | +46 31 776 10 00 | kontakt@astrazeneca.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 | Jun 22, 2015 | Feb 8, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000072658 | Non-ST Elevated Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077486 | Ticagrelor |
| ID | Term |
|---|---|
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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|
| Hsinchu |
| 300 |
| Taiwan |
| Research Site | Kaohsiung City | 80756 | Taiwan |
| Research Site | Kaohsiung City | 81362 | Taiwan |
| Research Site | Niao-Song-Shiang | 833 | Taiwan |
| Research Site | Taichung | Taiwan |
| Research Site | Tainan | 704 | Taiwan |
| Research Site | Tainan County | Taiwan |
| Research Site | Taipei | 104 | Taiwan |
| Research Site | Taipei | 11101 | Taiwan |
| Research Site | Taipei | 11217 | Taiwan |
| Research Site | Taipei | 11220 | Taiwan |
| Research Site | Taipei | 22060 | Taiwan |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
|
| Primary | Number of Participants With Bleeding Events (Major Bleedings) | Evaluation of PLATO (PLATelet inhibition and patient Outcomes)-defined major bleedings | Posted | Count of Participants | Participants | during 1year follow up with ticagrelor treatment |
|
|
|
| Primary | Number of Participants With Bleeding Events (Major and Minor Bleedings) | Evaluation of PLATO (PLATelet inhibition and patient Outcomes)-defined major + minor bleedings | Posted | Count of Participants | Participants | during 1year follow up with ticagrelor treatment |
|
|
|
| Primary | Number of Participants With Other Serious Adverse Event (SAEs) | Evaluation of serious adverse events other than bleedings | Posted | Count of Participants | Participants | during 1year follow up with ticagrelor treatment |
|
|
|
| Primary | Number of Participants With Major Cardiovascular Events | Evaluation of major cardiovascular events including cardiovascular death, myocardial infarction or stroke | Posted | Count of Participants | Participants | during 1year follow up with ticagrelor treatment |
|
|
|
| 108 |
| 23 |
| 108 |
| 45 |
| 108 |
| Sepsis | Infections and infestations | MedDRA version 19.1 | Systematic Assessment |
|
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 19.1 | Systematic Assessment |
|
| Haemorrhagic transformation stroke | Nervous system disorders | MedDRA version 19.1 | Systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA version 19.1 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA version 19.1 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA version 19.1 | Systematic Assessment |
|
| Acute coronary syndrome | Cardiac disorders | MedDRA version 19.1 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA version 19.1 | Systematic Assessment |
|
| Cardiogenic shock | Cardiac disorders | MedDRA version 19.1 | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA version 19.1 | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA version 19.1 | Systematic Assessment |
|
| Lymphorrhoea | Vascular disorders | MedDRA version 19.1 | Systematic Assessment |
|
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.1 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.1 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA version 19.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 19.1 | Systematic Assessment |
|
| Catheter site haematoma | General disorders | MedDRA version 19.1 | Systematic Assessment |
|
| Death | General disorders | MedDRA version 19.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA version 19.1 | Systematic Assessment |
|
| Sudden death | General disorders | MedDRA version 19.1 | Systematic Assessment |
|
| Vascular stent restenosis | General disorders | MedDRA version 19.1 | Systematic Assessment |
|
| Procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA version 19.1 | Systematic Assessment |
|
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA version 19.1 | Systematic Assessment |
|
| Tendon injury | Injury, poisoning and procedural complications | MedDRA version 19.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA version 19.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 19.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.1 | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA version 19.1 | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA version 19.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 19.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA version 19.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA version 19.1 | Systematic Assessment |
|
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| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |