Study of Blood Clotting After Transcatheter Atrial Septal Defect Closure

Thrombosis Clinical Trial

Official title:

A Multicentre, Randomized Controlled Study of Blood Clotting After Transcatheter Atrial Septal Defect Closure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01086046
• Other study ID #: cstc2009ab5033
• Status: Recruiting
• Phase: N/A
• First received: March 8, 2010
• Last updated: January 18, 2012
• Start date: January 2009
• Est. completion date: June 2012

Study information

• Verified date: January 2012
• Source: Third Military Medical University
• Contact: Jun Qin
• Phone: +86 023 68755601
• Email: qinjunqjqj[@]yahoo.com.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate blood clots after Percutaneous ASD Closure in different age, sexuality and defective diameter; evaluating the relationship of blood clotting with Occluder, injury of intima and inflammation;comparation of the effect and safety between different anticoagulation after Percutaneous ASD Repair; explore propose an optimal anticoagulation plan.

Description:

Atrial septal defect (ASD) is a common clinical congenital heart disease. It is estimated that the congenital heart disease increase in children by about 15 million annual in China , of which ASD accounted for 10% to 15%. Secundum ASD is the most common clinical type of ASD, of which about 70% is suited to tanscatheter close.With the cardiac catheterization advancing and the devices developing in recent years ,the method has gradually replaced open-chest surgical repair to the person with Secundum ASD. At present, the most widely used device is Amplatzer occluder. With the wide ues of the occlur,there has gradually emerged occluder thrombosis after closure.there are much different methods to antiplatelet and anticoagulation，not only in China but also in the world.so we perfom the study to evaluating the blood clotting after Percutaneous ASD Closure in different age, sexuality and defective diameter; evaluating the relationship of blood clotting with Occluder, injury of intima and inflammation;comparation of the effect and safety between different anticoagulation after Percutaneous ASD Repair; explore propose an optimal anticoagulation plan.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years to 60 Years

Eligibility

Inclusion Criteria:

• Age=3 years

• Diameter of defect=5mm and increasing volume load of right heart

• =36 mm secondary left to right shunt

• The distance between defective edge and coronaria venosus sinus, inferior caval vein, superior vena and pulmonary vein= 5 mm, between artrial-ventricular valve=7 mm

• The diameter of defect>Occluder

• No other cardiac anomalies need surgery intervention

Exclusion Criteria:

• Hypertension

• Coronary artery disease

• Diabetes

• Atrial fibrillation and oral contraceptive medication

• Aspro, clopidogrel and warfarin in 2 weeks.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Heart Septal Defects
• Heart Septal Defects, Atrial
• Thrombosis

Intervention

Drug:
• Low molecular weight heparin
Low molecular weight heparin sodium injection 1mg/kg 2 times in 24 hour Low molecular weight heparin sodium injection 1mg/kg 2 times per day in 3 days.

Locations

Country	Name	City	State
China	Cardiovascular Department, Xinqiao Hospital, the Third Military Medical University	Chongqing	Chongqing

Sponsors (2)

Lead Sponsor	Collaborator
Third Military Medical University	Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A Multicentre, Randomized Controlled Study of Blood Clotting After Percutaneous Atrial Septal Defect closure		within the first 90 days after closure	Yes