Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication Plavix is a P2Y 12 platelet inhibitor indicated for: Acute coronary syndrome – For patients with non–ST-segment elevation ACS (unstable angina [UA]/non–ST-elevation myocardial infarction [NSTEMI]), Plavix has been shown to reduce the rate of myocardial infarction (MI) and stroke. ( 1.1 ) – For patients with ST-elevation myocardial infarction (STEMI), Plavix has been shown to reduce the rate of MI and stroke. FDA label
Also known as Clopidogrel (SR25990), clopidogrel (SR25990C), SR25990, Plavix
Clopidogrel · 13 trials · 17 indications
All bleeding events experienced during the study period were collected as for any Adverse Event. The 'on-treatment' period was defined as the period from inclusion in the extension study up to 28 days after treatment discontinuation, and participants who experienced bleeding events during that period were counted.
For all reported bleeding events, the type and the etiology of the bleeding event were collected. Participants who experienced bleeding events during the 'on-treatment period' were counted by bleeding type and etiology.
Safety events of interest were: * Clinically significant bleeding, * Leukopenia, neutropenia or thrombocytopenia occurring as adverse drug reaction, * Elevated liver function values occurring as adverse drug reaction, * Permanent investigational product discontinuation due to skin disorders, gastrointestinal disorders, bleeding, hepatic disorders, or significant decreases in such tests as leukocytes, neutrophils or platelets occurring as adverse drug reaction.
The primary endpoint was the first occurence of any of the following events: Death (including heart transplant); Shunt thrombosis requiring intervention; Hospitalization for bi-directional Glenn procedure or any cardiac related intervention prior to 120 days of age following an event or a shunt narrowing considered to be of thrombotic nature by the blinded adjudication committee. Only the first event was counted.
The primary endpoint is the first occurrence of any of the following events: * Cardiovascular death (any death with a clear cardiovascular or unknown cause), * Myocardial Infarction (diagnosis of new Myocardial Infarction (MI) - nonfatal or fatal) * Stroke (presence of a new focal neurologic deficit thought to be vascular in origin, with signs or symptoms lasting more than 24 hours - nonfatal or fatal) reported between the randomization and Day 30 (inclusive), and validated by the blinded Event Adjudication Committee (EAC).
The primary event is the first occurence of any adjudicated component of the following cluster over the duration of follow-up : * stroke (nonfatal or fatal) * myocardial infarction (nonfatal or fatal) * non-CNS systemic embolism * vascular death The primary efficacy analysis is performed on the time from randomization to this primary event. Numbers of patients with the composite event over the duration of the follow-up are presented by arm group.
| Arm | Type | Description |
|---|---|---|
| Clopidogrel | EXPERIMENTAL | 75 mg clopidogrel once daily from Day 1 to Week 12 |
| Ticlopidine | ACTIVE_COMPARATOR | 200 mg ticlopidine once daily from Day 1 to Week 12 |
| Placebo | PLACEBO_COMPARATOR | 0.2 mL/kg/day matching placebo solution once daily. |
| Clopidogrel 0.2 mg/kg/day | EXPERIMENTAL | 0.2 mL/kg/day Clopidogrel reconstituted solution at 1mg/mL once daily. |
| Clopidogrel high dose treatment regimen + ASA high dose | EXPERIMENTAL | - |
| Clopidogrel high dose treatment regimen + ASA low dose | EXPERIMENTAL | - |
| Clopidogrel standard treatment regimen + ASA high dose | ACTIVE_COMPARATOR | - |
| Clopidogrel standard treatment regimen + ASA low dose | ACTIVE_COMPARATOR | - |
| 1 | EXPERIMENTAL | 300-mg loading dose of clopidogrel given ≥ 6 and ≤ 24 hours before PCI |
| 2 | EXPERIMENTAL | 600-mg loading dose of clopidogrel given ≥ 6 hours and ≤ 24 before PCI. |
| 3 | EXPERIMENTAL | 600-mg loading dose of clopidogrel given immediately (≤ 45 minutes) before PCI. |
| Clopidogrel + ASA | EXPERIMENTAL | Clopidogrel 75 mg once daily (od) plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion) |
| Placebo + ASA | PLACEBO_COMPARATOR | Matching placebo of clopidogrel 75 mg od plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion) |
| Name | Type | Description |
|---|---|---|
| clopidogrel (SR25990) | DRUG | oral administration (tablets) |
| ticlopidine | DRUG | oral administration (tablets) |
| Clopidogrel | DRUG | Form: reconstituted solution using Clopidogrel powder Route: oral or enteric Frequency: once daily Dose: daily dose adjusted for weight |
| placebo | DRUG | Form: reconstituted solution using matching placebo powder Route: oral or enteric Frequency: once daily Dose: daily dose adjusted for weight |
| acetylsalicyclic acid (ASA) | DRUG | oral administration |
| clopidogrel (SR25990C) | DRUG | - |
Inclusion Criteria: Documented symptomatic peripheral arterial disease (one or both of the following two primary criteria must be satisfied): * Current intermittent claudication with Ankle Brachial Index (ABI) \< 0.90 * A history of intermittent claudication together with previous related interven...
Clopidogrel is a small molecule drug developed by Sanofi (ticker SNY) for cardiovascular conditions. It is studied in acute coronary disease, acute coronary syndromes, arterial occlusive diseases, arteriosclerosis, atrial fibrillation, and congenital heart defects. Clopidogrel is in Phase 3 clinical development.
Clopidogrel targets P2RY12, a receptor on platelets. It acts as an antagonist at this target, meaning it blocks the receptor. This mechanism is intended to inhibit platelet activation and aggregation, which are key processes in thrombotic cardiovascular events.
Clopidogrel is developed by Sanofi, which trades under the ticker SNY. Sanofi is the company responsible for the clinical development of this drug.
Clopidogrel is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA for the indications being studied. The Phase 3 program includes completed trials in peripheral arterial disease, congenital heart defects, stable angina, and thrombosis.
Clopidogrel has been studied in several completed Phase 3 trials, including NCT00862420 in peripheral arterial disease, NCT00833703 in neonates and infants with congenital heart defects, NCT00821834 in stable angina and old myocardial infarction, and NCT00716924 in thrombosis. These trials enrolled a total of 25,086 participants.
Yes, Clopidogrel is also known by the research codes SR25990 and SR25990C. These alternative names refer to the same drug substance. Clopidogrel is the international nonproprietary name, while SR25990 and SR25990C are internal development codes used by Sanofi.