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Clinical Trial Details — Status: Unknown status

Administrative data

NCT number NCT01478282
Other study ID # FCRB
Secondary ID 2010-022985-29
Status Unknown status
Phase Phase 4
First received November 8, 2011
Last updated March 9, 2012
Start date January 2012
Est. completion date December 2012

Study information

Verified date March 2012
Source Fundacion Clinic per a la Recerca Biomédica
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

There is a lack of information on antidotes that could reverse the effects of new oral anticoagulants in patients that require a rapid restoration of their impaired hemostatic mechanisms. The present study seeks to improve the security and efficacy of the clinical practice with the new generation of oral anticoagulants.

OBJECTIVES:

1. To assess the action of new oral anticoagulants (dabigatran y rivaroxaban) on hemostasis with specific interest on possible interference with platelet interactions and coagulation mechanisms under flow conditions;

2. To evaluate comparatively the effects of coagulation factor concentrates of established efficacy (prothrombin complexes and rFVIIa) to reverse the alterations of hemostasis parameters induced by the new anticoagulants.

METHODOLOGY:

Studies will be performed ex vivo using blood samples from healthy individuals subjected to treatments with the new anticoagulants at doses of proven efficacy and safety (150mg/12 h for dabigatran and 20 mg/day for rivaroxaban). Blood samples from the participants will be spiked "in vitro" with know concentrations of the coagulation factors. Modifications in:

- morphometric parameters (platelet deposition and fibrin formation) in perfusion studies under flow conditions; and

- analytical tests evaluating changes in coagulation mechanisms (thrombin generation, ecarine and prothrombin times) will be determined.


Recruitment information / eligibility

Status Unknown status
Enrollment 10
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 60 Years
Eligibility Inclusion Criteria:

- Healthy volunteers ages from 21 to 60 years

- Approval informed consent

Exclusion Criteria:

- History of hepatic or kidney disease

- Previous history of hemorrhagic or thrombotic disease

- Pregnancy or breast feeding

- Concomitant use of drugs affecting hemostasis

- Use of medications of herbal treatments that could interfere with the pharmacokinetics or pharmacodynamics of the study drug (according to manufacturers label)

- Practice of risky sports (during the study period)

- Blood donation in the previous 3 months

Study Design


Intervention

Drug:
Rivaroxaban
20 mg/day, oral administration maintained for 5 days
Dabigatran
150 mg/12 hours, administered orally, treatment maintained for 5 days

Locations

Country Name City State
Spain Hospital Clinic, Fundació Clinic (FCRB) Barcelona

Sponsors (2)

Lead Sponsor Collaborator
Gines Escolar Ministry of Health, Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Modifications in hemostasis parameters. We will evaluate: a) the surface covered by platelets and fibrin on the subendothelium of vascular segments. Platelet interaction will be expressed as percentage of covered surface by platelets (%CS) and classified as contact, adhesion and aggregates depending of the size of interactions. Fibrin formation will be also evaluated as percentage of surface covered by fibrin (%F) and as the mean area of fibrin formed; and b) thrombin generation as lag time and maximum thrombin peak generation using a commercially available test (Technothrombin TGA, Technoclone GMBH). 5 days
Primary Changes observed after in vitro addition of coagulation factor concentrates We will re-evaluate: a) the surface covered by platelets and fibrin on the subendothelium of vascular segments. Platelet interaction will be expressed as percentage of covered surface by platelets (%CS) and classified as contact, adhesion and aggregates depending of the size of interactions. Fibrin formation will be also evaluated as percentage of surface covered by fibrin (%F) and as the mean area of fibrin formed; and b) thrombin generation as lag time and maximum thrombin peak generation using a commercially available test (Technothrombin TGA, Technoclone GMBH). 5 days
Secondary Measure other indirect biomarkers of the activation of the coagulation mechanisms. Prothrombin time, ecarin clotting time, and F1+2 fragments will be determined in frozen plasma samples. 5 days
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