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Reversal of the Antithrombotic Action of New Oral Anticoagulants

NCT01478282 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2012-03-12

No results posted yet for this study

Summary

The main goal of this study is to improve safety and efficiency of clinical practice with the new generation of oral anticoagulants.

1. To determine the effect of new oral anticoagulants (dabigatran and rivaroxaban) on platelets and coagulation mechanisms under flow conditions.
2. To evaluate the ability of the concentrates containing coagulation factors (PCCs and FVIIa) to reverse the effects induced by the new anticoagulants.

These studies will be carried out ex vivo in blood samples obtained from healthy volunteers undergoing oral anticoagulant therapy at doses of proven efficacy and safety used in previous clinical trials.

Conditions

Interventions

DRUG

Rivaroxaban

20 mg/day, oral administration maintained for 5 days

DRUG

Dabigatran

150 mg/12 hours, administered orally, treatment maintained for 5 days

Sponsors & Collaborators

  • Ministry of Health, Spain

    collaborator OTHER_GOV

  • Gines Escolar

    lead OTHER

Principal Investigators

  • Gines Escolar, M.D., Ph.D. · Fundacio Clinic per a la Reçerca Biomedica (FCRB)

Study Design

Allocation
NON_RANDOMIZED
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01478282 on ClinicalTrials.gov