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Poor enrollment
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This is a prospective, randomized pilot study in patients undergoing Sugical Aortic Valve Replacement (SAVR) and Transcatheter Aortic Valve Replacement (TAVR) to estimate the incidence of reduced leaflet motion and assess the impact of perioperative anticoagulation on the incidence of reduced leaflet motion.
This will be a pilot prospective randomized controlled trial.The study will enroll 50 adult patients scheduled to undergo SAVR and 50 adult patients scheduled to undergo TAVR. Subjects who satisfy Inclusion/Exclusion Criteria will be approached for informed consent. Those who give informed consent will be enrolled. After induction of anesthesia, a computer program will be used to randomize patients to one of the 2 treatment groups.
Patients will be seen at 4-6 weeks postoperatively for Transthoracic ECHO (TTE), 4 dimensional (4D), Multidetector computed tomography (MDCT) scan and review of medical history. Phone follow up at 6,9 and 12 months post-operatively.
Data from this pilot study will enable us to determine the feasibility of a larger randomized controlled clinical trial to investigate the phenomenon of reduced leaflet motion/subclinical valve thrombosis and, possibly, its clinical importance
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAVR Warfarin Arm | Experimental | Warfarin arm-(target INR of 2-3) |
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| TAVR Warfarin and Clopidogrel Arm | Experimental | Warfarin (target INR of 2-3) and Clopidogrel (75mg/day) arm |
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| SAVR Aspirin Arm | Experimental | Aspirin arm (81mg/day) |
|
| TAVR Aspirin and Clopidogrel Arm | Experimental | Aspirin (81mg/day) and Clopidogrel (75mg/day) arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAVR Warfarin | Drug | Warfarin treatment for 12 weeks with a target INR of 2-3 Warfarin treatment to begin on postoperative day 1-3 according to the patient's clinical status When warfarin treatment is discontinued, patients will be treated according to standard of care (aspirin 81 mg/day) indefinitely |
| Measure | Description | Time Frame |
|---|---|---|
| Leaflet Motion | Frequency of reduced leaflet motion related to perioperative anticoagulation with warfarin as measured by 4DMCT data. (<50% reduction in motion), moderately reduced (50 to 70% reduction), severely reduced (>70% reduction), or immobile (lack of motion of at least one valve leaflet). | 4-6 weeks post procedure |
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Inclusion Criteria:
Scheduled for SAVR or TAVR
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Douglas Johnston, M.D. | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | SAVR Warfarin Arm | Warfarin arm-(target INR of 2-3) SAVR Warfarin: Warfarin treatment for 12 weeks with a target INR of 2-3 Warfarin treatment to begin on postoperative day 1-3 according to the patient's clinical status When warfarin treatment is discontinued, patients will be treated according to standard of care (aspirin 81 mg/day) indefinitely |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | May 5, 2016 |
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| SAVR Aspirin | Drug | Aspirin (81 mg/day) to begin within 1-3 postoperative days according to the patient's clinical status and continue indefinitely per standard of care. |
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| TAVR Warfarin and clopidogrel | Drug | Begin Warfarin and clopidogrel (75 mg/day) treatment within 1-3 days postop for 12 weeks with a target INR of 2-3 When warfarin is discontinued, begin aspirin (81 mg/day) and continue aspirin/clopidogrel for 12 weeks At 24 weeks, study treatment will end and patients will be treated according to standard of care (aspirin 81 mg/day) indefinitely |
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| TAVR Aspirin and clopidogrel | Drug | Aspirin (81 mg/day) and clopidogrel (75 mg/day) in periprocedural period and continue for 24 weeks At 24 weeks, study treatment will end and patients will be treated according to standard of care (aspirin 81 mg/day) indefinitely |
|
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| FG001 |
| TAVR Warfarin and Clopidogrel Arm |
Warfarin (target INR of 2-3) and Clopidogrel (75mg/day) arm TAVR Warfarin and clopidogrel: Begin Warfarin and clopidogrel (75 mg/day) treatment within 1-3 days postop for 12 weeks with a target INR of 2-3 When warfarin is discontinued, begin aspirin (81 mg/day) and continue aspirin/clopidogrel for 12 weeks At 24 weeks, study treatment will end and patients will be treated according to standard of care (aspirin 81 mg/day) indefinitely |
| FG002 | SAVR Aspirin Arm | Aspirin arm (81mg/day) SAVR Aspirin: Aspirin (81 mg/day) to begin within 1-3 postoperative days according to the patient's clinical status and continue indefinitely per standard of care. |
| FG003 | TAVR Aspirin and Clopidogrel Arm | Aspirin (81mg/day) and Clopidogrel (75mg/day) arm TAVR Aspirin and clopidogrel: Aspirin (81 mg/day) and clopidogrel (75 mg/day) in periprocedural period and continue for 24 weeks At 24 weeks, study treatment will end and patients will be treated according to standard of care (aspirin 81 mg/day) indefinitely |
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| NOT COMPLETED |
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Study terminated - lack of enrollment
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| ID | Title | Description |
|---|---|---|
| BG000 | SAVR Warfarin Arm | Warfarin arm-(target INR of 2-3) SAVR Warfarin: Warfarin treatment for 12 weeks with a target INR of 2-3 Warfarin treatment to begin on postoperative day 1-3 according to the patient's clinical status When warfarin treatment is discontinued, patients will be treated according to standard of care (aspirin 81 mg/day) indefinitely |
| BG001 | TAVR Warfarin and Clopidogrel Arm | Warfarin (target INR of 2-3) and Clopidogrel (75mg/day) arm TAVR Warfarin and clopidogrel: Begin Warfarin and clopidogrel (75 mg/day) treatment within 1-3 days postop for 12 weeks with a target INR of 2-3 When warfarin is discontinued, begin aspirin (81 mg/day) and continue aspirin/clopidogrel for 12 weeks At 24 weeks, study treatment will end and patients will be treated according to standard of care (aspirin 81 mg/day) indefinitely |
| BG002 | SAVR Aspirin Arm | Aspirin arm (81mg/day) SAVR Aspirin: Aspirin (81 mg/day) to begin within 1-3 postoperative days according to the patient's clinical status and continue indefinitely per standard of care. |
| BG003 | TAVR Aspirin and Clopidogrel Arm | Aspirin (81mg/day) and Clopidogrel (75mg/day) arm TAVR Aspirin and clopidogrel: Aspirin (81 mg/day) and clopidogrel (75 mg/day) in periprocedural period and continue for 24 weeks At 24 weeks, study treatment will end and patients will be treated according to standard of care (aspirin 81 mg/day) indefinitely |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Study was terminated - low number of participants did not allow for data analysis | Study terminated - lack of enrollment | Count of Participants | Participants |
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| Sex: Female, Male | Data was not analyzed due to low enrollment | Data was not analyzed due to low enrollment - Study terminated | Count of Participants | Participants |
| |||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| 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 | Leaflet Motion | Frequency of reduced leaflet motion related to perioperative anticoagulation with warfarin as measured by 4DMCT data. (<50% reduction in motion), moderately reduced (50 to 70% reduction), severely reduced (>70% reduction), or immobile (lack of motion of at least one valve leaflet). | Study terminated | Posted | 4-6 weeks post procedure |
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1 year
Only 2 arms of the trial had enrollment (SAVR Warfarin / SAVR Aspirin). Adverse event information is reported only for these arms
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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 | SAVR Warfarin Arm | Warfarin arm-(target INR of 2-3) SAVR Warfarin: Warfarin treatment for 12 weeks with a target INR of 2-3 Warfarin treatment to begin on postoperative day 1-3 according to the patient's clinical status When warfarin treatment is discontinued, patients will be treated according to standard of care (aspirin 81 mg/day) indefinitely | 0 | 1 | 0 | 1 | 0 | 1 |
| EG001 | TAVR Warfarin and Clopidogrel Arm | Warfarin (target INR of 2-3) and Clopidogrel (75mg/day) arm TAVR Warfarin and clopidogrel: Begin Warfarin and clopidogrel (75 mg/day) treatment within 1-3 days postop for 12 weeks with a target INR of 2-3 When warfarin is discontinued, begin aspirin (81 mg/day) and continue aspirin/clopidogrel for 12 weeks At 24 weeks, study treatment will end and patients will be treated according to standard of care (aspirin 81 mg/day) indefinitely | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | SAVR Aspirin Arm | Aspirin arm (81mg/day) SAVR Aspirin: Aspirin (81 mg/day) to begin within 1-3 postoperative days according to the patient's clinical status and continue indefinitely per standard of care. | 0 | 2 | 0 | 2 | 0 | 2 |
| EG003 | TAVR Aspirin and Clopidogrel Arm | Aspirin (81mg/day) and Clopidogrel (75mg/day) arm TAVR Aspirin and clopidogrel: Aspirin (81 mg/day) and clopidogrel (75 mg/day) in periprocedural period and continue for 24 weeks At 24 weeks, study treatment will end and patients will be treated according to standard of care (aspirin 81 mg/day) indefinitely | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Douglas Johnston | Cleveland Clinic | 216-444-5613 | JOHNSTD3@ccf.org |
| Aug 16, 2017 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| D000077144 | Clopidogrel |
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
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