A Single-center, Prospective,Randomized Study of Antiplatelet Effects of Ticagrelor Versus Clopidogrel in Patients With Dual Anti-platelet Therapy After Coronary Artery Bypass Grafting

NCT02330640 | Completed Phase 4

• 1 other identifier: Zzheng
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to demonstrate that the onset of the antiplatelet effect of 90mg bid dose ticagrelor is more rapid and greater than 75 mg qd dose clopidogrel in patients undergoing CABG surgery.

Conditions

Antiplatelet Therapy of Coronary Artery Bypass

Keywords

CABG; antiplatelet therapy; ticagrelor

Outcome Measures

Primary Outcomes (1)

• IPA at 2hours

  the platelet inhibition (IPA %) measured by light-transmittance aggregometry at 2 hour in CABG patients after the first dose of study drug

  2 hours after the first dose of study drug

Secondary Outcomes (2)

• the inhibition of platelet function (IPA%) measured by LTA at 0h, 8h, 24h, 3day, and 30day after the first dose of study drug

  0h, 8h, 24h, 3day, and 30day after the first dose of study drug

• the platelet reactivity index at 0h, 2h, 8h, 24h，3day, and 30days

  0h, 2h, 8h, 24h，3day, and 30day after the first dose of study drug

Other Outcomes (2)

• The Number of Bleeding events according to BARC definition.

  30 days after the operation

• The number of MACE events including all-cause mortality， myocardial infarction, urgent re-operation for heart, cerebral infarction, cerebral hemorrhage.

  30 days after the operation

Study Arms (3)

ticagrelor

EXPERIMENTAL

90mg Bid for 30days after first dose

Drug: ticagrelor

clopidogrel

ACTIVE COMPARATOR

75mg Qd for 30days first dose

Drug: clopidogrel

asprin

OTHER

100mg Qd all patients will be given asprin 100mg Qd within 24hours after CABG

Drug: asprin

Interventions

ticagrelor DRUG

After the operation, the subjects will be randomized into two groups according to the proportion of 1:1; and receive the treatment of aspirin 100mg qd+ticagrelor 90mg bid or the treatment of aspirin 100mg qd+ clopidogrel 75mg qd. The study will plan to enroll 140 subjects in 12 months and the treatment will last for 30 days.

ticagrelor

clopidogrel DRUG

After the operation, the subjects will be randomized into two groups according to the proportion of 1:1; and receive the treatment of aspirin 100mg qd+ticagrelor 90mg bid or the treatment of aspirin 100mg qd+ clopidogrel 75mg qd. The study will plan to enroll 140 subjects in 12 months and the treatment will last for 30 days.

clopidogrel

asprin DRUG

All patients will be given asprin 100mg Qd within 24hours after operation,and will continue taking aspirin at the end of the study

asprin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female and/or male and ≥ 18 and \<80 years of age
• Isolated CABG for the first time
• either on- or off- pump

You may not qualify if:

• Combined valvular surgery.
• A second surgery.
• Emergency surgery (a selective operation which change to emergency surgery in some special medical condition).
• Serum creatinine\>130μmol/L.
• Oral clopidogrel therapy stops less than 5 days before the surgery.
• Oral anti-coagulation therapy (warfarin) that cannot be withheld.
• History of gastrointestinal or vaginal bleeding, Active pathological bleeding (e.g. active gastroduodenal ulcer or cerebral haemorrhage), history of postoperative gastrointestinal bleeding.
• Uric acid nephropathy, history of postoperative gastrointestinal bleeding.
• History of cerebral haemorrhage.
• Any other condition that may influence platelet count and function.
• Postoperative chest drainage \> 200 ml/hr for two hours and more, re-operation for bleeding with persistent cardiac tamponade.
• Treated with IABP or ECMO after operation.
• Any other condition that may put the patient at risk (e.g., recurrent ventricular arrhythmias, peri-operative myocardial infarction, cancer).
• Contraindication to aspirin, clopidogrel and ticagrelor or other reason that study drug should not be administered (e.g., hypersensitivity, moderate or severe liver disease).
• Previous enrollment in other investigational drug or device study within 30 days.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital: lead

Study Sites (1)

FuWaiHospital

Beijing, Beijing Municipality, 100000, China

Location

MeSH Terms

Interventions

Ticagrelor; Clopidogrel; acetylsalicylic acid lysinate

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiovascular Surgeon Professor

Model Details: Single center prospective randomized controlled study

Study Record Dates

• First Submitted: December 24, 2014
• First Posted: January 5, 2015
• Study Start: January 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: May 9, 2017

Record last verified: 2017-05

Locations

CN (1)