Trial Outcomes & Findings for Clopidogrel Pharmacogenomics Project (NCT NCT01097343)

Results Overview

P2Y12 Reaction Units are measured using the VerifyNow P2Y12 assay. Percent of patients with clopidogrel resistance defined by PRU value will be compared among low and high dose clopidogrel groups after 30 days of therapy.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

50 participants

Primary outcome timeframe

Approximately 90 days

Results posted on

2017-12-12

Participant Flow

50 patients with 2C19\*2 polymorphism were recruited to participate in a cross-over study comparing 75 vs. 150 mg of clopidogrel. 25 patients were randomized to start with 75 mg, and 25 patients started with 150 mg for 30 day dosing periods.

Cross-over study with two 30-day dosing periods. All patients were receiving chronic clopidogrel prior to enrollment after percutaneous coronary intervention.

Participant milestones

Participant milestones
Measure	75 mg First 30 Days, Followed by 150 mg 25 patients with the target allele were identified, and receive 75mg followed by 150 mg clopidogrel daily for two separate dosing periods of 30 days	150 mg First 30 Days, Followed by 75 mg 25 patients with the target allele were identified, and received 150 mg clopidogrel followed by 75 mg clopidogrel for two daily for separate dosing periods of 30 days
First Intervention- 30 Days STARTED	25	25
First Intervention- 30 Days COMPLETED	25	25
First Intervention- 30 Days NOT COMPLETED	0	0
Second Intervention- 30 Days STARTED	25	25
Second Intervention- 30 Days COMPLETED	25	25
Second Intervention- 30 Days NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clopidogrel Pharmacogenomics Project

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cross-over Study n=50 Participants All Study Participants
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=99 Participants
Age, Categorical >=65 years	23 Participants n=99 Participants
Age, Continuous	62.8 years STANDARD_DEVIATION 13.2 • n=99 Participants
Sex: Female, Male Female	15 Participants n=99 Participants
Sex: Female, Male Male	35 Participants n=99 Participants
Region of Enrollment United States	50 participants n=99 Participants

PRIMARY outcome

Timeframe: Approximately 90 days

Population: All patients completed the clinical protocol.

P2Y12 Reaction Units are measured using the VerifyNow P2Y12 assay. Percent of patients with clopidogrel resistance defined by PRU value will be compared among low and high dose clopidogrel groups after 30 days of therapy.

Outcome measures

Outcome measures
Measure	Cross-over Study- 75 mg Dose n=50 Participants Participants received standard dose clopidogrel (75 mg) and higher dose (150 mg) for 30 days	Cross-over Study - 150 mg Dose n=50 Participants Participants received standard dose clopidogrel (75 mg) and higher dose (150 mg) for 30 days
Clopidogrel Resistance, Defined by P2Y12 Reaction Units (PRU)Value >230	30 Number of Patients with PRU>230	18 Number of Patients with PRU>230

Adverse Events

75 mg Followed by 150 mg

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

150 mg Followed by 75 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	75 mg Followed by 150 mg n=25 participants at risk Cross-over study	150 mg Followed by 75 mg n=25 participants at risk Cross-over study
Gastrointestinal disorders Major Bleeding	4.0% 1/25 • Number of events 1 • Adverse event data was collected for 90 days after enrollment in the dosing study. Adverse event data was collected during patient visits and with a follow-up phone call 30 days after completion of the dosing protocol.	0.00% 0/25 • Adverse event data was collected for 90 days after enrollment in the dosing study. Adverse event data was collected during patient visits and with a follow-up phone call 30 days after completion of the dosing protocol.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Joseph S. Rossi

St. Vincent Medical Group

Phone: 765 482 0656

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place