Trial Outcomes & Findings for A Study to Evaluate the Discontinuation Effect of Clopidogrel After Drug Eluting Stent Implantation in Non-diabetic Patients (NCT NCT00493779)

Results Overview

Based on ANCOVA models performed on log scale controlling for site \& natural logarithm of baseline soluble CD40 Ligand value. Percent changes from baseline can be interpreted as the difference of biomarker timepoint value minus baseline value divided by baseline value. Positive percent change might indicate possible enhanced platelet activation.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

103 participants

Primary outcome timeframe

Week 1, Week 2, Week 3, Week 4 (primary timepoint)

Results posted on

2010-08-10

Participant Flow

103 subjects who were enrolled and treated with clopidogrel, were enrolled, of which 98 subjects had discontinued clopidogrel treatment and entered follow-up phase (study phase).

Participant milestones

Participant milestones
Measure	Clopidogrel Withdrawal Population All enrolled participants in whom clopidogrel treatment was discontinued.
Overall Study STARTED	98
Overall Study COMPLETED	97
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Clopidogrel Withdrawal Population All enrolled participants in whom clopidogrel treatment was discontinued.
Overall Study Logistical issue at site	1

Baseline Characteristics

A Study to Evaluate the Discontinuation Effect of Clopidogrel After Drug Eluting Stent Implantation in Non-diabetic Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Clopidogrel Withdrawal Population n=98 Participants All enrolled participants in whom clopidogrel treatment was discontinued.
Age Continuous	63 years n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	78 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	93 participants n=5 Participants
Race/Ethnicity, Customized Asian Oriental	5 participants n=5 Participants
Mean Baseline High Sensitivity C-Reactive Protein (hs-CRP)	1.70 mg/L STANDARD_DEVIATION 2.052 • n=5 Participants
Mean Baseline Plasma Soluble P-Selectin	44.59 ng/mL STANDARD_DEVIATION 14.898 • n=5 Participants
Mean Baseline Soluble CD40 Ligand	223.76 ng/L STANDARD_DEVIATION 186.513 • n=5 Participants

PRIMARY outcome

Timeframe: Week 1, Week 2, Week 3, Week 4 (primary timepoint)

Population: Number of participants in the biomarker analysis population having a baseline soluble CD40 Ligand value (n=95) and at least one post-clopidogrel withdrawal measurement for soluble CD40 Ligand value. No imputation technique for missing values was applied.

Based on ANCOVA models performed on log scale controlling for site \& natural logarithm of baseline soluble CD40 Ligand value. Percent changes from baseline can be interpreted as the difference of biomarker timepoint value minus baseline value divided by baseline value. Positive percent change might indicate possible enhanced platelet activation.

Outcome measures

Outcome measures
Measure	Biomarker Analysis Population n=95 Participants All participants in the Clopidogrel Withdrawal Population having a baseline and at least one post clopidogrel withdrawal measurement for any of the 3 biomarkers collected.
Adjusted Mean Percent Changes From Baseline in Soluble CD40 Ligand (sCD40L) Baseline value (units=ng/L) (n=95)	223.76 percent change Standard Error 19.14
Adjusted Mean Percent Changes From Baseline in Soluble CD40 Ligand (sCD40L) Mean Percent Change from Baseline at Week 1 (n=92)	35.04 percent change Standard Error 10.37
Adjusted Mean Percent Changes From Baseline in Soluble CD40 Ligand (sCD40L) Mean Percent Change from Baseline at Week 2 (n=91)	38.88 percent change Standard Error 10.76
Adjusted Mean Percent Changes From Baseline in Soluble CD40 Ligand (sCD40L) Mean Percent Change from Baseline at Week 3 (n=91)	32.74 percent change Standard Error 9.68
Adjusted Mean Percent Changes From Baseline in Soluble CD40 Ligand (sCD40L) Mean Percent Change from Baseline at Week 4 (n=89)	39.42 percent change Standard Error 11.07

SECONDARY outcome

Timeframe: Week 1, Week 2, Week 3, Week 4

Population: Number of patients in the biomarker analysis population having baseline Plasma Soluble P-selectin value (n=95) and at least one post-clopidogrel withdrawal measurement for Plasma Soluble P-selectin value. No imputation technique for missing values was applied.

Based on ANCOVA models performed on log scale controlling for site and natural logarithm of baseline Plasma Soluble P-selectin value. Percent changes from baseline can be interpreted as difference of biomarker timepoint value minus baseline value divided by baseline value. Positive percent change is known to be mediated by increases in sCD40L.

Outcome measures

Outcome measures
Measure	Biomarker Analysis Population n=95 Participants All participants in the Clopidogrel Withdrawal Population having a baseline and at least one post clopidogrel withdrawal measurement for any of the 3 biomarkers collected.
Adjusted Mean Percent Changes From Baseline in Plasma Soluble P-Selectin Baseline Value (units=ng/mL) (n=95)	44.59 percent change Standard Error 1.53
Adjusted Mean Percent Changes From Baseline in Plasma Soluble P-Selectin Mean Percent Change from Baseline at Week 1 (n=92)	9.00 percent change Standard Error 2.38
Adjusted Mean Percent Changes From Baseline in Plasma Soluble P-Selectin Mean Percent Change from Baseline at Week 2 (n=91)	11.10 percent change Standard Error 2.11
Adjusted Mean Percent Changes From Baseline in Plasma Soluble P-Selectin Mean Percent Change from Baseline at Week 3 (n=91)	3.63 percent change Standard Error 2.69
Adjusted Mean Percent Changes From Baseline in Plasma Soluble P-Selectin Mean Percent Change from Baseline at Week 4 (n=89)	1.90 percent change Standard Error 2.76

SECONDARY outcome

Timeframe: Week 1, Week 2, Week 3, Week 4

Population: Number of patients in the biomarker analysis population having baseline hs-CRP value and at least one post clopidogrel withdrawal measurement for hs-CRP value. No imputation technique for missing values was applied.

ANCOVA models performed on log scale controlling for site \& natural logarithm of baseline hs-CRP. Back-transformed mean percent changes are presented. Percent changes from baseline can be interpreted as difference of biomarker timepoint value - baseline value ÷ baseline value. Since there is no measure of platelet inhibition or overall thrombogenicity assay presented here, a negative percent change for this measure can not be judged on its own as indicating improvement.

Outcome measures

Outcome measures
Measure	Biomarker Analysis Population n=98 Participants All participants in the Clopidogrel Withdrawal Population having a baseline and at least one post clopidogrel withdrawal measurement for any of the 3 biomarkers collected.
Adjusted Mean Percent Changes From Baseline in Hs-CRP Baseline Value (units=mg/L) (n=98)	1.70 percent change Standard Error 0.21
Adjusted Mean Percent Changes From Baseline in Hs-CRP Mean Percent Change from Baseline at Week 1 (n=97)	-20.59 percent change Standard Error 6.76
Adjusted Mean Percent Changes From Baseline in Hs-CRP Mean Percent Change from Baseline at Week 2 (n=95)	-22.89 percent change Standard Error 6.78
Adjusted Mean Percent Changes From Baseline in Hs-CRP Mean Percent Change from Baseline at Week 3 (n=96)	-19.32 percent change Standard Error 8.22
Adjusted Mean Percent Changes From Baseline in Hs-CRP Mean Percent Change from Baseline at Week 4 (n=96)	-17.70 percent change Standard Error 8.48

SECONDARY outcome

Timeframe: Throughout 4-week follow-up period

Population: All enrolled patients in whom clopidogrel treatment was discontinued.

An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a patient or clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.

Outcome measures

Outcome measures
Measure	Biomarker Analysis Population n=98 Participants All participants in the Clopidogrel Withdrawal Population having a baseline and at least one post clopidogrel withdrawal measurement for any of the 3 biomarkers collected.
Adverse Events (AE) / Serious Adverse Events (SAE)Deaths, and AEs Leading to Discontinuation of Follow-up Deaths	0 Participants
Adverse Events (AE) / Serious Adverse Events (SAE)Deaths, and AEs Leading to Discontinuation of Follow-up Any AE	20 Participants
Adverse Events (AE) / Serious Adverse Events (SAE)Deaths, and AEs Leading to Discontinuation of Follow-up AEs leading up to Discontinuation	0 Participants
Adverse Events (AE) / Serious Adverse Events (SAE)Deaths, and AEs Leading to Discontinuation of Follow-up SAEs	2 Participants

Adverse Events

Clopidogrel Withdrawal Population

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Clopidogrel Withdrawal Population n=98 participants at risk All enrolled participants in whom clopidogrel treatment was discontinued.
General disorders Non-cardiac chest pain	1.0% 1/98
Cardiac disorders Angina unstable	1.0% 1/98

Other adverse events

Adverse event data not reported

Additional Information

BMS Study Director

Bristol-Myers Squibb

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Publication restrictions are in place

Restriction type: OTHER