Trial · NCT02392104

Prospective Evaluation of an Extended Interval of INR Follow-up in a VA Anticoagulation Service

NCT02392104, Not applicable, Completed, William S. Middleton Memorial Veterans Hospital; results first posted 2019-12-11

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Prospective Evaluation of an Extended Interval of INR Follow-up in a VA Anticoagulation Service. Trials, record NCT02392104. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02392104

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Prospective Evaluation of an Extended Interval of INR Follow-up in a VA Anticoagulation Service
NCT number: NCT02392104
Status: Completed
Phases: Not applicable
Enrollment: 51 participants, actual
Lead sponsor: William S. Middleton Memorial Veterans Hospital
Conditions: Anticoagulation
Interventions: Warfarin
First posted: 2015-03-18
Last updated: 2019-12-11
Results first posted: 2019-12-11

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Rates of Participant Accrual	up to 2.25 years	Number of participants who enroll vs. number of individuals invited
Primary	Number of Participants Able to be Scheduled for at Least One 12-week Interval	24 months	This outcome will determine the number of participants able to be scheduled for at least one 12-week interval
Primary	Number of Participants Scheduled for at Least 4 Consecutive 12-week Intervals	24 months	The outcome will determine the number of participants scheduled for at least 4 consecutive 12-week intervals
Secondary	Change in Frequency of Appointments From Baseline to End of Study	12 and 24 months	This outcome will evaluate the change in frequency of appointments from baseline to end of study (at 12 and 24 months)
Secondary	Bleeding and Thromboembolic Events From Baseline	24 months	This outcome will determine the number of bleeding and thromboembolic events from baseline
Secondary	Change in Time in Therapeutic Range From Baseline	6, 12, and 24 months	The outcome will evaluate the change in time in therapeutic range (TTR) from baseline (intention-to-treat)
Secondary	Patient Satisfaction Through Total DASS Score	baseline, 6 months, 12 months, 24 months	Patient satisfaction through total DASS score. DASS = Duke Anticoagulation Satisfaction Scale. 25-item scale.Higher numbers indicate worsening satisfaction ranging from 25-175. Seven-point ordinal scale ("not at all" = 1, "very much" = 7).
Other	Frequency and Type of Protocol Deviations From Both Participants and Study Staff	Up to 2.25 years	This outcome determines the frequency and type of protocol deviations from both participants and study staff

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Rates of Participant Accrual	up to 2.25 years	107 invited to participate in the study, not all enrolled or started the study	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants Able to be Scheduled for at Least One 12-week Interval	24 months		Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants Scheduled for at Least 4 Consecutive 12-week Intervals	24 months		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change in Frequency of Appointments From Baseline to End of Study	12 and 24 months	44 participants remained in the study at 12 months	visits per 12 months	MEAN
SECONDARY	Bleeding and Thromboembolic Events From Baseline	24 months		events	NUMBER
SECONDARY	Change in Time in Therapeutic Range From Baseline	6, 12, and 24 months	49 participants at 12 months, 44 participants at 24 months	change in percentage of TTR	MEAN
SECONDARY	Patient Satisfaction Through Total DASS Score	baseline, 6 months, 12 months, 24 months		score on a scale	MEAN
OTHER_PRE_SPECIFIED	Frequency and Type of Protocol Deviations From Both Participants and Study Staff	Up to 2.25 years	634 eligible participant visits	percentage of visits	NUMBER

Source ClinicalTrials.gov

Results by group20

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Rates of Participant Accrual	Intervention Arm	Number of patients invted	107		Participants
Rates of Participant Accrual	Intervention Arm	Patient enrolled in study	51		Participants
Rates of Participant Accrual	Intervention Arm	Patients analyzed for study	50		Participants
Number of Participants Able to be Scheduled for at Least One 12-week Interval	Intervention Arm		36		Participants
Number of Participants Scheduled for at Least 4 Consecutive 12-week Intervals	Intervention Arm		15		Participants
Change in Frequency of Appointments From Baseline to End of Study	Intervention Arm	Planned anticoagulation visits (baseline)	12.67	Standard Deviation 2.56	visits per 12 months
Change in Frequency of Appointments From Baseline to End of Study	Intervention Arm	Planned anticoagulation visits (0-12 months)	10.43	Standard Deviation 3.58	visits per 12 months
Bleeding and Thromboembolic Events From Baseline	Intervention Arm	Number of thromboembolic events	2		events
Bleeding and Thromboembolic Events From Baseline	Intervention Arm	Number of major bleeding events	6		events
Bleeding and Thromboembolic Events From Baseline	Intervention Arm	Number of serious bleeding events	16		events

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Extended INR Follow-up Interval Group	50
Overall Study	COMPLETED	Extended INR Follow-up Interval Group	39
Overall Study	NOT COMPLETED	Extended INR Follow-up Interval Group	11

Source ClinicalTrials.gov

Adverse events24

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Thromboembolism	Vascular disorders	Intervention Arm	1	50	2
other	Major bleeding	Blood and lymphatic system disorders	Intervention Arm	6	50	6
other	Serious bleeding	Blood and lymphatic system disorders	Intervention Arm	16	50	22
serious	Multiple myeloma	Blood and lymphatic system disorders	Intervention Arm	1	50	1
serious	Aortic valve disease	Cardiac disorders	Intervention Arm	2	50	2
serious	Chest pain - cardiac	Cardiac disorders	Intervention Arm	1	50	2
serious	Heart failure	Cardiac disorders	Intervention Arm	3	50	5
serious	Colitis	Gastrointestinal disorders	Intervention Arm	1	50	1
serious	Colonic hemorrhage	Gastrointestinal disorders	Intervention Arm	1	50	1
serious	Hemorrhoidal hemorrhage	Gastrointestinal disorders	Intervention Arm	1	50	1

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Intervention Arm	0	50
Total, other adverse events	Intervention Arm	19	50
Total, serious adverse events	Intervention Arm	15	50

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
31752504	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02392104

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