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| Name | Class |
|---|---|
| Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | OTHER |
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Platelet activation and aggregation leads to myocardial infarction. Platelet P2Y12 receptors are essential for platelet activation. Antagonists against the P2Y12 receptor, which are established in secondary prevention of myocardial infarction, have unexplained anti-inflammatory effects. A novel P2Y12 receptor antagonist ticagrelor reduced infection-related mortality compared to clopidogrel, previous standard treatment for patients with myocardial infarction. Activated platelets release pro-inflammatory and procoagulant platelet extracellular vesicles. The investigators assume that decrease in infection-related mortality in patients treated with ticagrelor may be explained by greater inhibition of the release of platelet vesicles by ticagrelor, compared to clopidogrel. This study is expected to identify an additional mechanism of action of ticagrelor, which might contribute to the observed clinical benefits in patients treated with ticagrelor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ticagrelor | Active Comparator | Ticagrelor: oral, 180 mg once (loading dose) followed by 90 mg twice daily (maintenance dose) |
|
| Clopidogrel | Active Comparator | Clopidogrel: oral, 300 mg or 600 mg once (loading dose) followed by 75 mg once daily (maintenance dose) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ticagrelor | Drug | Comparison of ticagrelor with another antiplatelet drug (clopidogrel) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of Platelet Extracellular Vesicles/ml | Concentration of platelet extracellular vesicles/ml measured with flow cytometry | 6 months following the beginning of antiplatelet therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of Extracellular Vesicles Exposing Fibrinogen | Concentration of extracellular vesicles exposing fibrinogen/ ml measured with flow cytometry | 6 months |
| Concentration of Extracellular Vesicles Exposing Phosphatidylserine |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aleksandra Gasecka, MD | 1st Chair and Department of Cardiology, Medical University of Warsaw | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laboratory of Experimental Clinical Chemistry, Academic Medical Centre of the University of Amsterdam | Amsterdam | Netherlands | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29671861 | Background | Gasecka A, Nieuwland R, van der Pol E, Hajji N, Cwiek A, Pluta K, Konwerski M, Filipiak KJ. P2Y12 antagonist ticagrelor inhibits the release of procoagulant extracellular vesicles from activated platelets. Cardiol J. 2019;26(6):782-789. doi: 10.5603/CJ.a2018.0045. Epub 2018 Apr 19. |
| Label | URL |
|---|---|
| Related Info | View source |
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The data will be presented in a collective form. If a particular study participant presents with an especially high or low concentration of the studied biomarker , the participant's characteristics may be described separately in a way which does not allow to identify the participant's personal data.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ticagrelor | Ticagrelor: oral, 180 mg once (loading dose) followed by 90 mg twice daily (maintenance dose) |
| FG001 | Clopidogrel | Clopidogrel: oral, 300 mg or 600 mg once (loading dose) followed by 75 mg once daily (maintenance dose) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ticagrelor | Ticagrelor: oral, 180 mg once (loading dose) followed by 90 mg twice daily (maintenance dose) |
| BG001 | Clopidogrel | Clopidogrel: oral, 300 mg or 600 mg once (loading dose) followed by 75 mg once daily (maintenance dose) |
| 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 |
| 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 | Concentration of Platelet Extracellular Vesicles/ml | Concentration of platelet extracellular vesicles/ml measured with flow cytometry | Posted | Median | Inter-Quartile Range | Platelet Extracellular Vesicles/mL | 6 months following the beginning of antiplatelet therapy |
|
6 months
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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 | Ticagrelor: oral, 180 mg once (loading dose) followed by 90 mg twice daily (maintenance dose) 27 patients One major bleeding event from the gynecologic tract |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| One major bleeding event from the gynecologic tract | Reproductive system and breast disorders | Non-systematic Assessment | In a patient who was eventually diagnosed with endometrial cancer. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aleksandra Gasecka, MD, PhD | 1st Chair and Department of Cardiology, Medical University of Warsaw | +48225991951 | alesandra.gasecka@wum.edu.pl |
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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 | Dec 21, 2016 | Nov 28, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D007249 | Inflammation |
| D013927 | Thrombosis |
| 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 |
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| Clopidogrel | Drug | Comparison of clopidogrel with another antiplatelet drug (ticagrelor) |
|
|
Concentration of extracellular vesicles exposing phosphatidylserine/ml measured with flow cytometry
| 6 months |
| Concentration of Extracellular Vesicles From Endothelial Cells | The concentrations of extracellular vesicles from endothelial cells/ ml measured with flow cytometry | 6 months |
| Concentration of Extracellular Vesicles From Leukocytes | Concentration of extracellular vesicles from leukocytes/ ml measured with flow cytometry | 6 months |
| 1st Chair and Department of Cardiology, Medical University of Warsaw |
| Warsaw |
| Poland |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Concentration of Extracellular Vesicles Exposing Fibrinogen | Concentration of extracellular vesicles exposing fibrinogen/ ml measured with flow cytometry | Not Posted | 6 months | Participants |
| Secondary | Concentration of Extracellular Vesicles Exposing Phosphatidylserine | Concentration of extracellular vesicles exposing phosphatidylserine/ml measured with flow cytometry | Not Posted | 6 months | Participants |
| Secondary | Concentration of Extracellular Vesicles From Endothelial Cells | The concentrations of extracellular vesicles from endothelial cells/ ml measured with flow cytometry | Not Posted | 6 months | Participants |
| Secondary | Concentration of Extracellular Vesicles From Leukocytes | Concentration of extracellular vesicles from leukocytes/ ml measured with flow cytometry | Not Posted | 6 months | Participants |
| 0 |
| 30 |
| 1 |
| 30 |
| 0 |
| 30 |
| EG001 | Clopidogrel | Clopidogrel: oral, 300 mg or 600 mg once (loading dose) followed by 75 mg once daily (maintenance dose) 28 patients One major bleeding event from a diabetic foot ulcer | 0 | 30 | 1 | 30 | 0 | 30 |
|
| One major bleeding event from a diabetic foot ulcer | Skin and subcutaneous tissue disorders | Non-systematic Assessment | In a male patient who had dysregulated diabetes and infection of a diabetic foot. |
|
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| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D016769 | Embolism and Thrombosis |
| 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 |