# ANTICOAGULANT THERAPY IN OLDER PATIENTS

> **NIH NIH R01** · CASE WESTERN RESERVE UNIVERSITY · 1991 · $199,730

## Abstract

Although anticoagulant therapy has proven benefits, it frequently causes
serious bleeding--especially in older patients.  The main goal of this
study is to improve the use of anticoagulant therapy in older persons by
preventing bleeding complications and by seeking better laboratory
predictors of complications.  The study is also concerned with
comprehensive health-related outcomes.  Most importantly, bleeding during
anticoagulant therapy is viewed as a paradigm for drug-induced illness in
older persons.  The proposed scientific methods and clinical strategies are
expected to be valuable prototypes for future programs.

Preliminary studies work and by others have (1) established predictors of
anticoagulant-related bleeding (including older age), (2) shown that
increased patient participation in care and physician consultation may
prevent complications and improve health-related outcomes, and (3) found
that new ways of monitoring warfarin may improve therapy.  In the proposed
project, it is hypothesized that a specific intervention prevents major
bleeding during long-term anticoagulant therapy in patients greater than 65
years.  The intervention is the "Patient Participation Program" (PPP),
which includes prothrombin time (PT) self-monitoring, patient training and
education, and physician consultation from a specialized anticoagulant
service.  Testing the PPP involves a randomized clinical trial, which
provides an opportunity to seek better pharmacological predictors of
bleeding and thromboembolism.

An incremental research plan has been designed with three specific aims.
First, the patient-focused components of the PPP (PT self-monitoring,
training in information-seeking, and education) will be piloted in 25
patients.  Second, to determine the efficacy of the PPP, 325 patients
greater than 65 years starting long-term anticoagulant therapy in two
hospitals will be randomly assigned to receive usual care or the PPP plus
usual care.  The study has 80% power of detecting the expected 50%
reduction in the cumulative frequency of major bleeding, which is the main
outcome.  Effects on health-related quality of life, frequency of
thromboembolism, and mortality rates will also be measured.  Third, the
study will determine whether recently defined and more specific
pharmacologic indices of anticoagulation--concentrations of specific
prothrombin isomers, R(+)- and S(-)-warfarin, and vitamin K1--provide
better prediction of bleeding and thromboembolism in the study population.

The proposed project will test a novel approach to the prevention of
serious complications of anticoagulant therapy in older persons and will
assess the value of new pharmacologic methods for monitoring warfarin
therapy.  The findings will provide valuable insights into--and a prototype
for--the prevention of drug-induced illness in older persons.

## Key facts

- **NIH application ID:** 3121561
- **Project number:** 1R01AG009657-01
- **Recipient organization:** CASE WESTERN RESERVE UNIVERSITY
- **SAM.gov UEI:** HJMKEF7EJW69
- **Principal Investigator:** C. SETH LANDEFELD
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 1991
- **Award amount:** $199,730
- **Award type:** 1
- **Project period:** 1991-07-01 → 1996-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/3121561

## Citation

> US National Institutes of Health, RePORTER application 3121561, ANTICOAGULANT THERAPY IN OLDER PATIENTS (1R01AG009657-01). Retrieved via MORVS 2026-10-25 from https://api.morvs.ai/grant/nih/3121561. Licensed CC0.

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