Trials Sponsors Conditions Drugs Pricing

Conditions

Aortic Valve Disorder

Outcome Measures

Primary Outcomes (1)

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

Study Arms (4)

SAVR Warfarin Arm

EXPERIMENTAL

Warfarin arm-(target INR of 2-3)

Drug: SAVR Warfarin

TAVR Warfarin and Clopidogrel Arm

EXPERIMENTAL

Warfarin (target INR of 2-3) and Clopidogrel (75mg/day) arm

Drug: TAVR Warfarin and clopidogrel

SAVR Aspirin Arm

EXPERIMENTAL

Aspirin arm (81mg/day)

Drug: SAVR Aspirin

Interventions

SAVR WarfarinDrug

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

Also known as: Coumadiin

SAVR Warfarin Arm

SAVR AspirinDrug

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.

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Grouped treatment entry
TAVR Warfarin and clopidogrel
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record
Grouped treatment entry
TAVR Aspirin and clopidogrel
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Scheduled for SAVR or TAVR
Age \> 18 years

Sponsors & Collaborators

The Cleveland Clinic
Otherlead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

MeSH Terms

Conditions

Aortic Valve Disease

Interventions

AspirinClopidogrelWarfarin

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Results Point of Contact

Title: Dr. Douglas Johnston
Organization: Cleveland Clinic

Study Officials

Douglas Johnston, M.D.
The Cleveland Clinic
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes

Enrollment

3 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: OUTCOMES ASSESSOR
Purpose: DIAGNOSTIC
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: MD

Study Record Dates

First Submitted

February 16, 2016

First Posted

March 2, 2016

Study Start

February 2016

Actual (reported)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (4)

SAVR Warfarin Arm

TAVR Warfarin and Clopidogrel Arm

SAVR Aspirin Arm

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

TAVR Aspirin and Clopidogrel Arm

You may not qualify if:

Data Sharing

Source record

Documents

Locations