Ignite Creation Date:
2024-05-05 @ 11:57 PM
Last Modification Date:
2024-10-26 @ 10:42 AM
Study NCT ID:
NCT01452152
Status:
TERMINATED
Last Update Posted:
2022-03-16
First Post:
2011-10-10
Brief Title:
Pharmacogenomics of Anti-platelet Intervention-2 PAPI-2 Study
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Pharmacogenomics of Anti-platelet Intervention-2 PAPI-2 Study A Prospective Multicenter Randomized Trial of Genotype-directed G-DVersus Standard of Care SOCAnti-platelet Therapy
Status:
TERMINATED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated by study sponsor
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAPI-2
Brief Summary:
It is standard treatment to take anti-platelet medication after cardiac catheterization and stent placement to help prevent the formation of blood clots that may cause heart attack or stroke The most commonly used anti-platelet medicine is clopidogrel Plavix However researchers have found that people vary in their response to clopidogrel in part because of differences in their genes Prasugrel Effientis another anti-platelet medication used to prevent clots The genetic differences that affect clopidogrel response do not affect prasugrel response Recently the FDA added a warning to the label of clopidogrel to notify doctors and patients with certain genetic differences may not get the full benefit from clopidogrel Despite this genetic testing for these variations is not usually done in standard medical practice The purpose of this study is to see if patients with certain gene differences have fewer major cardiac events after stent placement if they are given anti-platelet therapy guided by their individual genetic type compared to standard anti-platelet therapy
Detailed Description:
Over a three-year period a total of 7200 patients undergoing percutaneous coronary intervention PCI in whom dual anti-platelet therapy is indicated for at least one year and meet the eligibility criteria will be recruited from five or more clinical sites Patients presenting to the cardiac clinics emergency departments catheterization laboratories and other acute care units eg CCU who will have coronary angiography or have had angiography and PCI will be offered participation Following informed consent patients will have baseline data and specimens collected and eligibility confirmed Patients will be randomized in equal numbers to the G-D arm or SOC arm Immediately following randomization a blood sample from patients assigned to the G-D arm will be sent for CYP2C19 genotype analysis Upon receipt of CYP2C19 genotype results patients randomized to the G-D arm with the CYP2C19 11 genotype extensive metabolizers and 117 and 1717 genotypes ultrarapid metabolizers will receive clopidogrel 75 mgday plus aspirin 81-162 mgday group a Those with 12 13 217 and 317 genotypes intermediate metabolizers and those with 22 23 and 33 genotypes poor metabolizers will receive prasugrel 5-10 mgday plus aspirin 81-162 mgday group b Patients randomized to the SOC arm will not be genotyped prospectively They will receive dual anti-platelet therapy guided by the judgment of their treating physician according to standard medical practice irrespective of genotype group c Optionally a subgroup of patients will return at 10 days after the randomization visit for platelet aggregation studies
If our hypothesis is correct ie that in intermediate and poor metabolizers G-D anti-platelet therapy results in fewer cardiovascular events and has less or equivalent bleeding complications compared to SOC therapy and is cost effective this prospective randomized clinical trial will provide the evidence base to implement genotype-directed anti-platelet treatment algorithms broadly into clinical practice
If our hypothesis is correct ie that in intermediate and poor metabolizers G-D anti-platelet therapy results in fewer cardiovascular events and has less or equivalent bleeding complications compared to SOC therapy and is cost effective this prospective randomized clinical trial will provide the evidence base to implement genotype-directed anti-platelet treatment algorithms broadly into clinical practice
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 9U01HL105198-06 | NIH | None | httpsreporternihgovquickSearch9U01HL105198-06 |