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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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This study is a randomized, placebo-controlled, single blind clinical trial. Seventy patients with ESRD on chronic HD and a functioning AVF will be recruited. The following data will be documented on each patient: 1-Age/gender/race/body weight/cause of ESRD 2-Vintage of HD 3-Time since access was placed 4-Type and place of access and blood flow rate of access 5-History of prior access problems 6-Comorbid conditions (Hypertension, coronary artery disease, Diabetes Mellitus, Bleeding problems, peripheral vascular disease). 7-Current medications (Coumadin, Erythropoiesis stimulating agents, heparin, other antiplatelets, digoxin, statins). Patients will be randomized into two groups to receive: Group 1: Ticagrelor 90 mg PO BID Group 2: Placebo drug PO BID.
This study is a randomized, placebo-controlled, single blind clinical trial. Seventy patients with ESRD on chronic HD and a functioning AVF will be recruited. Consent form will be obtained. History and physical, dialysis parameters and laboratory data (CBC, CMP, PTT & INR) will be obtained throughout the study. The following data will be documented on each patient: 1-Age/gender/race/body weight/cause of ESRD 2-Vintage of HD 3-Time since access was placed 4-Type and place of access and blood flow rate of access 5-History of prior access problems 6-Comorbid conditions (Hypertension, coronary artery disease, Diabetes Mellitus, Bleeding problems, peripheral vascular disease). 7-Current medications (Coumadin, Erythropoiesis stimulating agents, heparin, other antiplatelets, digoxin, statins). Patients will be randomized into two groups to receive: Group 1: Ticagrelor 90 mg PO BID Group 2: Placebo drug PO BID.
Subjects will have a screening visit and if they qualify for the study they will have 18 additional visits. All of these visits will occur while the subjects are at their normal dialysis treatment. Subjects will be randomized to either the Ticagrelor group or the placebo group. Subjects will be on study medication for 6 months then they will have a follow up period off drug for 6 months. Subjects will be seen twice a month while on study medication and once a month in the follow up period. While the subjects are on study medication the study team will assess any side effects of the study medication and put their relation to the study drug at each study visit. The study team will use clinical monitoring as suggested by Beathard (21). The study team will document the subject's adherence to the study, if they are hospitalized and what caused their hospitalization. A monthly intra-access flow will be obtained using ultrasound dilution by transonics as part of standard of care. Any change in the clinical assessment of the access, prolonged bleeding (>20 minutes) after removal of needles, trend of decreasing intra-access blood flow as determined by transonic (> 25% or original flow), or an access flow rate < 400 ml/min, will prompt a referral for a fistulogram. If confirmed stenosis (>50% stenosis of the access diameter) an intervention (angioplasty) will be performed. This intervention is part of the subjects standard of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ticagrelor | Active Comparator | 90 mg of ticagrelor to be given orally twice a day for 6 months |
|
| Placebo | Placebo Comparator | Placebo drug to be given twice a day for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ticagrelor | Drug | ticagrelor 90 mg twice a day for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility and Safety of Ticagrelor in Hemodialysis Patients | Number of Participants with prolonged bleeding (>30 minutes) after removal of needles | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Efficacy of Ticagrelor to Preserve Patency of Hemodialysis Vascular Access | Percentage of participants with stenosis free survival | 1 year |
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Inclusion Criteria:
- Patients on chronic hemodialysis with a functioning arterio-venous fistula
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia - Hospital West Kidney Center Dialysis | Charlottesville | Virginia | 22908 | United States |
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10 of 54 consented subjects failed screening and were not assigned to the study arms.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | 90 mg of Ticagrelor to be given orally twice a day for 6 months |
| FG001 | Placebo | Placebo drug to be given twice a day for 6 months |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment |
|
| |||||||||||||||||||||
| Follow-up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | 90 mg of Ticagrelor to be given orally twice a day for 6 months |
| BG001 | Placebo | Placebo drug to be given twice a day for 6 months |
| 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 | Feasibility and Safety of Ticagrelor in Hemodialysis Patients | Number of Participants with prolonged bleeding (>30 minutes) after removal of needles | Posted | Count of Participants | Participants | 6 months |
|
|
1 year
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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 | Treatment | 90 mg of Ticagrelor to be given orally twice a day for 6 months | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cardiac arrest | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| increased diarrhea | Gastrointestinal disorders | Systematic Assessment |
The results may be affected by the enrollment that did not reach a goal of 70 subjects with only 34 subject or 48.5% of the projected number completing the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emaad Abdel-Rahman, MD | University of Virginia | 434-924-5820 | ea6n@virginia.edu |
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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 19, 2018 | Feb 23, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 26, 2018 | Feb 23, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic 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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| Placebo | Drug | 1 pill twice a day for 6 months |
|
| Death |
|
| Adverse Event |
|
| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Participants |
|
|
|
| Secondary | Treatment Efficacy of Ticagrelor to Preserve Patency of Hemodialysis Vascular Access | Percentage of participants with stenosis free survival | Posted | Number | 95% Confidence Interval | percentage of participants | 1 year |
|
|
|
|
| 17 |
| 1 |
| 17 |
| 3 |
| 17 |
| EG001 | Placebo | Placebo drug to be given twice a day for 6 months | 1 | 17 | 1 | 17 | 2 | 17 |
| myocardial infarction | Cardiac disorders | Systematic Assessment |
|
| transient ischemic attack - stroke | Blood and lymphatic system disorders | Systematic Assessment |
|
| tickling feeling in head | General disorders | Systematic Assessment |
|
| bruise on hand | General disorders | Systematic Assessment |
|
| bloody drops on penis | Blood and lymphatic system disorders | Systematic Assessment |
|
| cold | Infections and infestations | Systematic Assessment |
|
| worsening pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |