Different Dosage of Domestic and Imported Clopidogrel on the Platelet Inhibition Ratio in Patients Undergoing PCI

Coronary Heart Disease Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03006835
• Other study ID #: ky20162060-2
• Status: Not yet recruiting
• Phase: Phase 4
• First received: December 27, 2016
• Last updated: December 27, 2016
• Start date: January 2017
• Est. completion date: December 2017

Study information

• Verified date: December 2016
• Source: Xijing Hospital
• Contact: yi liu, doctor
• Phone: 86-029-84775183
• Email: 1391643423[@]qq.com
• Is FDA regulated: No
• Health authority: China: Chinese Medical Association
• Study type: Interventional

Clinical Trial Summary

This is a single-center, randomized, single-blind, investigator-initiated, pharmacological study with a parallel design. Patients with non-ACS undergoing primary percutaneous coronary intervention will be randomized after informed consent, in a 1:1:1:1 ratio to the following treatment groups:

Group Α: Domestic Clopidogrel 300mg as a loading dose before PCI, followed by 75mg per day.

Group B: Domestic Clopidogrel 600mg as a loading dose before PCI, followed by 75mg per day.

Group B: Imported Clopidogrel 300mg as a loading dose before PCI, followed by 75mg per day.

Group D: Imported Clopidogrel 600mg as a loading dose before PCI, followed by 75mg per day.

Platelet inhibition ratio assessment by thrombelastogram will be performed，2 hours after the loading dose(Day 0)， 6 hours after thrombelastogram (Day 0), 30 day after thrombelastogram. Documentation of major adverse cardiac events (death, myocardial infarction, stroke, revascularization procedure with PCI or CABG) and serious adverse events (bleeding, other adverse events)will be performed until Day 30.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. The patient is scheduled to undergo non-urgent PCI

2. The patient is between 18 and 75 years of age (inclusive) and willing to comply with the protocol

3. The patient or legally acceptable representative is able to read and give written informed consent and has signed an informed consent form approved by the Investigator's IRB/IEC

Exclusion Criteria:

1. Estimated or measured weight < 55 kg

2. Acute non-ST-segment elevation myocardial infarction (NSTEMI) or ST-segment elevation myocardial infarction (STEMI) within 7 days prior to PCI

3. Uncontrolled hypertension at the time of initial study drug administration defined as measured systolic blood pressure > 190 mm Hg or diastolic blood pressure > 108 mm Hg

4. Patient has received a clopidogrel loading dose (=300 mg) within 30 days prior to randomization; patients on maintenance clopidogrel may be enrolled

5. Administration of thrombolytic agents, fondaparinux, or oral anticoagulants (e.g., warfarin) within the 7 days prior to PCI

6. Estimated creatinine clearance (e.g. Cockcroft-Gault) < 45 mL/min

7. Anemia with hemoglobin level < 10 g/dL

8. Thrombocytopenia (platelet count < 100,000/mm3)

9. ALT and/or AST > 2.5 x the ULN or other indication of clinically significant hepatic dysfunction

10. Facial or head trauma within the last 30 days

11. Intraocular hemorrhage within the last 30 days

12. Gastrointestinal bleeding within the last 30 days

13. Active bleeding, or history of a bleeding disorder or known intracranial vascular malformation

14. Known allergy or contraindication to aspirin, heparin, clopidogrel, or to any contrast media

15. Participation in any investigational drug study within 30 days prior to enrollment.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Drug:
• Clopidogrel

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Xijing Hospital	Shenzhen Salubris Pharmaceuticals Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ADP- induced platelet inhibition rate		2 hours after the loading dose	No
Primary	ADP- induced platelet inhibition rate		6 hours after the loading dose	No
Primary	ADP- induced platelet inhibition rate		30 days after the loading dose	No
Secondary	R value (min)		2 hours after the loading dose	No