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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04897997
Other study ID # 20210502VandoeuvreFranceEurope
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 6, 2020
Est. completion date September 30, 2022

Study information

Verified date May 2021
Source Central Hospital, Nancy, France
Contact Edoardo Camenzind, Professor
Phone +33 3 83 15 5339
Email edoardo@camenzind-cardio.net
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

analyzing influence of smoking on patients anti-coagulation status as assessed by ACT measurements during coronary angioplasty


Description:

During angioplasty, activated clotting time (ACT) measurements are recommended to attest the correct anticoagulation level and if anticoagulation levels are suboptimal after the two first boluses, additional unfractionated heparin (UFH) injections are recommended until obtention of a therapeutic ACT values (250-350s). The study hypothesis was that the procoagulant effect of the tobacco may be responsible of reduced anticoagulation levels after standardized UFH administrations and thus presenting an UFH resistance requiring increased UFH dosages to obtain a therapeutic ACT values.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date September 30, 2022
Est. primary completion date August 31, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - any patient older than 18 years needing a diagnostic coronarography was eligible for enrollment Exclusion Criteria: - unconscious patient - any patient presenting with one of the following characteristic known to impact either on ACT or aPTT measurements as: oral anticoagulation medication (anti-vitamin K and non-vitamin K antagonist oral anticoagulants [NOAC]), fondaparinux or LMWH usage, coagulopathy defined as prothrombin time < 50 % or thrombopenia < 50 000 G/L, declared or observed thrombophilia defined as antithrombin < 50%, baseline aPTT values with a ratio patient/control > 1.2 presence of lupus anticoagulant, connective tissue disease, active cancer - a person as defined by the law articles L. 1121-5, L. 1121-7 et L1121-8 of the Code de la santé publique, France (pregnant, parturient women or breastfeeding women, legally adult patient under legal protection measure [tutelage, protection of vulnerable adults]), - a person as defined by the law articles L. 3212-1 et L. 3213-1 of the Code de la santé publique, France (legally adult patient unable to consent, person with legal or administrative freedom restriction or person under psychiatric treatment)

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
coronarography and angioplasty
selective angiography of the coronaries and angioplasty of significant culprit lesion(s)

Locations

Country Name City State
France University Hospital Nancy Brabois Vandœuvre-lès-Nancy

Sponsors (1)

Lead Sponsor Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary ACT values after injection the first injection of a standardized unfractionated heparin bolus between non-smoking and actively smoking patients comparison of ACT values after injection of two standardized UFH boluses between non-smoking and actively smoking patients (non-smoker group versus active smoker group) during the intervention
Primary ACT values after injection the second injection of a standardized unfractionated heparin bolus between non-smoking and actively smoking patients comparison of ACT values after injection of two standardized UFH boluses between non-smoking and actively smoking patients (non-smoker group versus active smoker group) immediately after the intervention
Secondary ACT values after injection of the first standardized UFH bolus in ex-smokers ACT values after injection of the first standardized UFH bolus in ex-smokers requiring a coronarography followed by a PTCA during the intervention
Secondary ACT values after injection of the second standardized UFH bolus in ex-smokers ACT values after injection of the second standardized UFH bolus in ex-smokers requiring a coronarography followed by a PTCA immediately after the intervention
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