Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01046942
Other study ID # H-C-2007-0057
Secondary ID
Status Recruiting
Phase Phase 3
First received January 11, 2010
Last updated September 23, 2013
Start date November 2008
Est. completion date September 2014

Study information

Verified date September 2013
Source Rigshospitalet, Denmark
Contact Sulman Rafiq, MD
Phone (0045) 35458728
Email sulman_raf@hotmail.com
Is FDA regulated No
Health authority Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Medicines Agency
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether adding clopidogrel to aspirin after coronary bypass operation (CABG) improves graft patency, in patients that have preoperatively increased platelet activity(hypercoagulable) and therefore greater risk of graft occlusion( thrombosis).


Description:

Graft patency after CABG is reported to 80-90% worldwide 1 year following surgery. In the immediate period after surgery, and the following month, graft occlusion mainly occurs due to thrombosis.

Patients with platelet hyperreactivity have increased risk of thromboembolic events, including graft occlusion, myocardial infarction and stroke. Therefore intensifying the antiplatelet therapy in these patients, must be anticipated to have beneficial effects.

Hypercoagulable patients are identified with thrombelastography(TEG) as having a Maximal Amplitude(MA)>69, thereafter randomized to either clopidogrel(3months) and aspirin or aspirin alone. At 3 months postoperative after surgery the coronary graft patency is assessed with Multislice CT scan.

Pre- and postoperatively, and then again at 3month followup, TEG and multiplate aggregometry are performed to assess platelet reactivity and resistance to aspirin and clopidogrel.


Recruitment information / eligibility

Status Recruiting
Enrollment 250
Est. completion date September 2014
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Elective/subacute multivessel CABG

- Isolated CABG procedure, no concomitant surgery

- age > 18 years

- Able to give informed consent

Exclusion Criteria:

- Myocardial infarction <48h of surgery

- Prior CABG surgery within 1 month

- Cardiac Shock within 48h of surgery

- Atrial fibrillation

- Anticoagulation therapy with VKA

- ICH/TCI within 30 days

- Prior peptic ulcerĀ· Platelet count < 150 E9

- Ongoing bleeding

- Known platelet disease

- Allergic to aspirin or clopidogrel

- Liver disease with elevated ALAT/ASAT> 1,5x normal

- Creatinine> 0,120mmol/l

- Contrast allergy

- Alcohol or narcotics abuse

- Pregnancy

- Not able to give informed consent

- Geographically not available for follow up

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
Clopidogrel+acetylsalicylic acid
loading dose clopidogrel 300mg on second postoperative day. Thereafter 75mg clopidogrel daily for 3 months Aspirin 75mg daily, started within 24 hours after surgery
acetylsalicylic acid
aspirin 75 mg daily, started 6-24 hours after surgery

Locations

Country Name City State
Denmark Dep. of cardiothoracic surgery, Rigshospitalet Copenhagen Kbh

Sponsors (1)

Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Graft patency at 3 months Graft patency of Saphenous vein grafts will be significantly higher in TEG-Hypercoagulable patients on clopidogrel+aspirin vs. aspirin alone. 3 months No
Secondary Rate of other thromboembolic events( e.g. myocardial infarction,stroke, pulmonary embolus etc.)and cardiovascular death In the TEG-Hypercoagulable intervention group (clopidogrel+aspirin) we expect significantly lower rates, of other thromboembolic events (e.g. myocardial infarction,stroke, pulmonary embolism etc) and cardiovascular death, compared to TEG-Hypercoagulable patients on aspirin monotherapy. 3 months No
Secondary Assessing coagulation profile pre- and postoperatively, including aspirin and clopidogrel resistance 3 months No
See also
  Status Clinical Trial Phase
Completed NCT03826043 - THrombo-Embolic Event in Onco-hematology N/A
Recruiting NCT04398628 - ATHN Transcends: A Natural History Study of Non-Neoplastic Hematologic Disorders
Completed NCT05426564 - Exploratory Assessment of the Quantra® System in Adult ECMO Patients
Not yet recruiting NCT05830916 - Diagnostic Role of Antiphospholipid Antibodies and Microparticles in Immune Thrombocytopenic Patients With Thrombosis
Recruiting NCT02972385 - Pharmacogenomics of Warfarin in Hispanics and Latinos
Completed NCT02917213 - Imaging Silent Brain Infarct And Thrombosis in Acute Myocardial Infarction
Completed NCT02439190 - CV004-007 Thrombosis Chamber Study Phase 1
Completed NCT02526628 - Thrombosis and Neurocognition in Klinefelter Syndrome
Completed NCT02341638 - Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986141 in Healthy Subjects Phase 1
Completed NCT01855516 - Partial Thromboplastin Time After 72 Hours of Antithrombotic Prophylaxis Using Unfractionated Heparin N/A
Unknown status NCT00983112 - Evicel Study on the Peri-operative Bleeding in Total Knee Prothesis Surgery Phase 4
Completed NCT00412464 - Pilot Dose Finding and Pharmacokinetic Study of Fondaparinux in Children With Thrombosis Phase 1
Completed NCT00479362 - Anticoagulant Therapy During Pacemaker Implantation Phase 4
Completed NCT00346424 - Safety and Efficacy Study of Alfimeprase in Subjects With Occluded Central Catheters Phase 3
Completed NCT00143715 - Oral Vitamin K for Warfarin Associated Coagulopathy Phase 3
Terminated NCT00303420 - Alteplase for Blood Flow Restoration in Hemodialysis Catheters Phase 4
Completed NCT00039858 - Evaluation of Argatroban Injection in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin Phase 4
Completed NCT00007410 - Genetic Architecture of Plasma T-PA and PAI-1 N/A
Completed NCT00000538 - Dietary Effects on Lipoproteins and Thrombogenic Activity Phase 3
Completed NCT00005436 - Lupus Cohort--Thrombotic Events and Coronary Artery Disease N/A