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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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The Objectives of this study are:
This is a randomized placebo-controlled double-blind pilot trial. Study procedures will be conducted at Stanford University Medical Center, and standard-of-care (SOC) procedures will be conducted at Stanford and it's affiliated hospitals (Veteran's Affairs Palo Alto Health Care System and the Stanford Vascular Surgery Clinic at Valley Medical Center). The investigators expect to enroll 128 patients. Patients will be assigned to treatment groups with a 1:1 randomization in blocks of 4 at the conclusion of the AV fistula creation. Patients will be stratified based on fistula location (lower arm versus upper arm).
Objectives:
This is a randomized placebo-controlled double-blind pilot trial. Study procedures will be conducted at Stanford University Medical Center, and standard-of-care (SOC) procedures will be conducted at Stanford and it's affiliated hospitals (Veteran's Affairs Palo Alto Health Care System and the Stanford Vascular Surgery Clinic at Valley Medical Center). The investigators expect to enroll 128 patients. Patients will be assigned to treatment groups with a 1:1 randomization in blocks of 4 at the conclusion of the AV fistula creation. Patients will be stratified based on fistula location (lower arm versus upper arm).
Participation in this study will not affect standard care of patients with AV fistulae receiving hemodialysis. The only additional treatment is administration of the study drug or placebo and additional monitoring, including one additional ultrasound, for 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vorapaxar intervention | Active Comparator | This arm will receive the study drug: Vorapaxar sulfate. The investigators expect to enroll 128 patients. Patients will be assigned to treatment groups with a 1:1 randomization in blocks of 4 at the conclusion of the AV fistula creation. Patients will be stratified based on fistula location (lower arm versus upper arm). |
|
| Placebo intervention | Placebo Comparator | This arm will receive the matching placebo. The investigators expect to enroll 128 patients. Patients will be assigned to treatment groups with a 1:1 randomization in blocks of 4 at the conclusion of the AV fistula creation. Patients will be stratified based on fistula location (lower arm versus upper arm). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vorapaxar sulfate | Drug | The study drug (12-week supply of study drug) will be dispensed to enrolled patients on the first day following surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to AV Fistula Functional Maturation | Time to AV fistula functional maturation (defined as successful cannulation of the AV fistula for six hemodialysis sessions within three weeks). | up to 238 days |
| Measure | Description | Time Frame |
|---|---|---|
| Count of Participants With AV Fistula Use | Participants able to use their AV fistula for dialysis within 180 days of surgery were considered to have met the outcome. | up to 238 days |
| Count Participants With AV Fistula Patency |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew W Mell, MD, MS | Stanford University | Principal Investigator |
| Kenneth W Mahaffey, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Univeristy | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 5923023 | Background | Brescia MJ, Cimino JE, Appel K, Hurwich BJ. Chronic hemodialysis using venipuncture and a surgically created arteriovenous fistula. N Engl J Med. 1966 Nov 17;275(20):1089-92. doi: 10.1056/NEJM196611172752002. No abstract available. | |
| 4600820 | Background | Andrassy K, Malluche H, Bornefeld H, Comberg M, Ritz E, Jesdinsky H, Mohring K. Prevention of p.o. clotting of av. cimino fistulae with acetylsalicyl acid. Results of a prospective double blind study. Klin Wochenschr. 1974 Apr 1;52(7):348-9. doi: 10.1007/BF01468835. No abstract available. |
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17 participants were enrolled, 13 were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vorapaxar Intervention | Participants were randomized to receive vorapaxar sulfate for 12 weeks (2.5 mg orally once daily). |
| FG001 | Placebo Intervention | Participants were randomized to receive placebo to match vorapaxar sulfate for 12 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vorapaxar Intervention | Participants were randomized to receive vorapaxar sulfate for 12 weeks (2.5 mg orally once daily). |
| BG001 | Placebo Intervention | Participants were randomized to receive placebo to match vorapaxar sulfate for 12 weeks. |
| 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 | Time to AV Fistula Functional Maturation | Time to AV fistula functional maturation (defined as successful cannulation of the AV fistula for six hemodialysis sessions within three weeks). | Pre-specified time for assessment of this Outcome Measure was up to 180 days, but data collected is out of window due to delayed and rescheduled visits. | Posted | Median | Inter-Quartile Range | Days to functional maturation | up to 238 days |
|
Up to 238 days
Pre-specified time for assessment of Adverse Events was up to 180 days, but data collected is out of window due to delayed and rescheduled visits.
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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 | Vorapaxar Intervention | Participants were randomized to receive vorapaxar sulfate for 12 weeks (2.08 mg orally once daily). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aplastic crisis in setting of sickle cell anemia | Blood and lymphatic system disorders | Systematic Assessment |
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The study did not reach its planned enrollment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ken Mahaffey MD | Stanford University | 650.723.3096 | kmahaf@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 11, 2018 | Sep 11, 2018 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | May 3, 2018 | Nov 30, 2018 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D001164 | Arteriovenous Fistula |
| ID | Term |
|---|---|
| D001165 | Arteriovenous Malformations |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C530299 | vorapaxar |
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|
| Placebo | Drug | The placebo will match the study drug, vorapaxar sulfate, in appearance. A 12-week supply will be dispensed to enrolled patients on the first day following surgery. |
|
Criteria for outcome: AV fistula patency at 150-180 days, with at least 50% increase in vein diameter by ultrasound compared with preoperative vein diameter measurement.
| 150-238 days |
| Count of All Participants With Bleeding Events | Bleeding events according to GUSTO (criteria for bleeding: Severe, Moderate or Mild) and BARC (bleeding criteria Type 0-5, with 0 being no bleeding and 5 referring to probable or definite fatal bleeding) Criteria | up to 238 days |
| 12191977 | Background | Crowther MA, Clase CM, Margetts PJ, Julian J, Lambert K, Sneath D, Nagai R, Wilson S, Ingram AJ. Low-intensity warfarin is ineffective for the prevention of PTFE graft failure in patients on hemodialysis: a randomized controlled trial. J Am Soc Nephrol. 2002 Sep;13(9):2331-7. doi: 10.1097/01.asn.0000027356.16598.99. |
| 3888153 | Background | Fiskerstrand CE, Thompson IW, Burnet ME, Williams P, Anderton JL. Double-blind randomized trial of the effect of ticlopidine in arteriovenous fistulas for hemodialysis. Artif Organs. 1985 Feb;9(1):61-3. doi: 10.1111/j.1525-1594.1985.tb04349.x. |
| 18843633 | Background | Osborn G, Escofet X, Da Silva A. Medical adjuvant treatment to increase patency of arteriovenous fistulae and grafts. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD002786. doi: 10.1002/14651858.CD002786.pub2. |
| 10740671 | Background | Kaufman JS. Antithrombotic agents and the prevention of access thrombosis. Semin Dial. 2000 Jan-Feb;13(1):40-6. doi: 10.1046/j.1525-139x.2000.00012.x. No abstract available. |
| 16317810 | Background | Dember LM, Kaufman JS, Beck GJ, Dixon BS, Gassman JJ, Greene T, Himmelfarb J, Hunsicker LG, Kusek JW, Lawson JH, Middleton JP, Radeva M, Schwab SJ, Whiting JF, Feldman HI; DAC Study Group. Design of the Dialysis Access Consortium (DAC) Clopidogrel Prevention of Early AV Fistula Thrombosis Trial. Clin Trials. 2005;2(5):413-22. doi: 10.1191/1740774505cn118oa. |
| 17095716 | Background | Hirano K. The roles of proteinase-activated receptors in the vascular physiology and pathophysiology. Arterioscler Thromb Vasc Biol. 2007 Jan;27(1):27-36. doi: 10.1161/01.ATV.0000251995.73307.2d. Epub 2006 Nov 9. |
| 22443427 | Background | Morrow DA, Braunwald E, Bonaca MP, Ameriso SF, Dalby AJ, Fish MP, Fox KA, Lipka LJ, Liu X, Nicolau JC, Ophuis AJ, Paolasso E, Scirica BM, Spinar J, Theroux P, Wiviott SD, Strony J, Murphy SA; TRA 2P-TIMI 50 Steering Committee and Investigators. Vorapaxar in the secondary prevention of atherothrombotic events. N Engl J Med. 2012 Apr 12;366(15):1404-13. doi: 10.1056/NEJMoa1200933. Epub 2012 Mar 24. |
| 22077816 | Background | Tricoci P, Huang Z, Held C, Moliterno DJ, Armstrong PW, Van de Werf F, White HD, Aylward PE, Wallentin L, Chen E, Lokhnygina Y, Pei J, Leonardi S, Rorick TL, Kilian AM, Jennings LH, Ambrosio G, Bode C, Cequier A, Cornel JH, Diaz R, Erkan A, Huber K, Hudson MP, Jiang L, Jukema JW, Lewis BS, Lincoff AM, Montalescot G, Nicolau JC, Ogawa H, Pfisterer M, Prieto JC, Ruzyllo W, Sinnaeve PR, Storey RF, Valgimigli M, Whellan DJ, Widimsky P, Strony J, Harrington RA, Mahaffey KW; TRACER Investigators. Thrombin-receptor antagonist vorapaxar in acute coronary syndromes. N Engl J Med. 2012 Jan 5;366(1):20-33. doi: 10.1056/NEJMoa1109719. Epub 2011 Nov 13. |
| 22315147 | Background | Kosoglou T, Kraft WK, Kumar B, Statkevich P, Xuan F, Ma L, Jennings LK, Schiller JE, Langdon RB, Cutler DL. Pharmacokinetics and pharmacodynamics of the novel PAR-1 antagonist vorapaxar in patients with end-stage renal disease. Eur J Clin Pharmacol. 2012 Jul;68(7):1049-56. doi: 10.1007/s00228-012-1217-6. Epub 2012 Feb 8. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Secondary | Count of Participants With AV Fistula Use | Participants able to use their AV fistula for dialysis within 180 days of surgery were considered to have met the outcome. | Pre-specified time for assessment of this Outcome Measure was up to 180 days, but data collected is out of window due to delayed and rescheduled visits. | Posted | Count of Participants | Participants | up to 238 days |
|
|
|
| Secondary | Count Participants With AV Fistula Patency | Criteria for outcome: AV fistula patency at 150-180 days, with at least 50% increase in vein diameter by ultrasound compared with preoperative vein diameter measurement. | Pre-specified time for assessment of this Outcome Measure was up to 180 days, but data collected is out of window due to delayed and rescheduled visits. | Posted | Count of Participants | Participants | 150-238 days |
|
|
|
| Secondary | Count of All Participants With Bleeding Events | Bleeding events according to GUSTO (criteria for bleeding: Severe, Moderate or Mild) and BARC (bleeding criteria Type 0-5, with 0 being no bleeding and 5 referring to probable or definite fatal bleeding) Criteria | Pre-specified time for assessment of this Outcome Measure was up to 180 days, but data collected is out of window due to delayed and rescheduled visits. | Posted | Count of Participants | Participants | up to 238 days |
|
|
|
| 0 |
| 6 |
| 3 |
| 6 |
| 0 |
| 6 |
| EG001 | Placebo Intervention | Participants were randomized to receive placebo to match vorapaxar sulfate for 12 weeks. | 0 | 7 | 3 | 7 | 0 | 7 |
| Superior vena cava syndrome | Cardiac disorders | Systematic Assessment |
|
| Melena due to duodenal ulceration | Gastrointestinal disorders | Systematic Assessment |
|
| Dilation of left ureteral-ileal stricture | Renal and urinary disorders | Systematic Assessment |
|
| Shortness of breath due to volume overload | Renal and urinary disorders | Systematic Assessment |
|
| Renal transplant | Renal and urinary disorders | Systematic Assessment |
|
| Clogged nephrostomy tube | Renal and urinary disorders | Systematic Assessment |
|
| Miliary tuberculosis | Infections and infestations | Systematic Assessment |
|
| Community acquired pneumonia | Infections and infestations | Systematic Assessment |
|
| Severe fever to due catheter infection | Infections and infestations | Systematic Assessment |
|
| Abdominal abscess | Infections and infestations | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | Systematic Assessment |
|
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| D016157 | Vascular Fistula |
| D014652 | Vascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |