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Clopidogrel Optimal Loading Dose Usage to Reduce Recurrent EveNTs/Optimal Antiplatelet Strategy for InterventionS (CURRENT/OASIS7)

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00335452
First received: June 8, 2006
Last updated: November 9, 2010
Last verified: November 2010
History of Changes
Results First Received: September 15, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Acute Coronary Disease
Angina Unstable
Interventions: Drug: Clopidogrel
Drug: acetylsalicyclic acid (ASA)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
25086 patients were enrolled and randomized between June 2006 and August 2009 in 597 sites in 39 countries. Because the observed overall blinded event rate was substantially lower than expected, the number of patients to be enrolled was increased from 18000 to 20000, then to 25000.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Treatment assignment was performed through an automated voice randomization service (AreS). At the same time, the AReS provided allocation to a Clopidogrel treatment regimen according to a pre-defined randomization list and to a ASA dose according to a factorial design.

Reporting Groups
  Description
Clopidogrel 300/75/75 mg + ASA Low Dose

Day 1: Clopidogrel 300 mg loading dose + ASA ≥ 300 mg

Day 2 to Day 7: Clopidogrel 75 mg + ASA 75-100 mg

Day 8 to Day 30: Clopidogrel 75 mg + ASA 75-100 mg
Clopidogrel 300/75/75 mg + ASA High Dose

Day 1: Clopidogrel 300 mg loading dose + ASA ≥ 300 mg

Day 2 to Day 7: Clopidogrel 75 mg + ASA 300-325 mg

Day 8 to Day 30: Clopidogrel 75 mg + ASA 300-325 mg
Clopidogrel 600/150/75 mg + ASA Low Dose

Day 1: Clopidogrel 600 mg loading dose + ASA ≥ 300 mg

Day 2 to Day 7: Clopidogrel 150 mg + ASA 75-100 mg

Day 8 to Day 30: Clopidogrel 75 mg + ASA 75-100 mg
Clopidogrel 600/150/75 mg + ASA High Dose

Day 1: Clopidogrel 600 mg loading dose + ASA ≥ 300 mg

Day 2 to Day 7: Clopidogrel 150 mg + ASA 300-325 mg

Day 8 to Day 30: Clopidogrel 75 mg + ASA 300-325 mg

Participant Flow:   Overall Study
    Clopidogrel 300/75/75 mg + ASA Low Dose     Clopidogrel 300/75/75 mg + ASA High Dose     Clopidogrel 600/150/75 mg + ASA Low Dose     Clopidogrel 600/150/75 mg + ASA High Dose  
STARTED     6312 [1]   6254 [1]   6267 [1]   6253 [1]
TREATED WITH CLOPIDOGREL     6271     6218     6228     6217  
TREATED WITH ASA     6302     6251     6261     6247  
COMPLETED     6154 [2]   6107 [2]   6108 [2]   6122 [2]
NOT COMPLETED     158     147     159     131  
Death                 156                 144                 158                 129  
Lost to Follow-up                 2                 3                 1                 2  
[1] Randomized
[2] Completed 30 days follow-up period



  Baseline Characteristics
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Reporting Groups
  Description
Clopidogrel 300/75/75 mg + ASA Low Dose No text entered.
Clopidogrel 300/75/75 mg + ASA High Dose No text entered.
Clopidogrel 600/150/75 mg + ASA Low Dose No text entered.
Clopidogrel 600/150/75 mg + ASA High Dose No text entered.
Total Total of all reporting groups

Baseline Measures
    Clopidogrel 300/75/75 mg + ASA Low Dose     Clopidogrel 300/75/75 mg + ASA High Dose     Clopidogrel 600/150/75 mg + ASA Low Dose     Clopidogrel 600/150/75 mg + ASA High Dose     Total  
Number of Participants  
[units: participants]
 		  6312     6254     6267     6253     25086  
Age  
[units: years]
Mean ± Standard Deviation 		  61.3  ± 11.7     61.5  ± 11.7     61.2  ± 11.8     61.4  ± 11.9     61.3  ± 11.8  
Age, Customized  
[units: participants]
 		         
< 65 years     3792     3740     3787     3735     15054  
65 - 74 years     1573     1576     1543     1543     6235  
≥ 75 years     947     937     937     975     3796  
Missing     0     1     0     0     1  
Gender  
[units: participants]
 		         
Female     1702     1756     1671     1742     6871  
Male     4610     4498     4596     4511     18215  
Region of Enrollment  
[units: participants]
 		         
Argentina     182     159     162     174     677  
Australia     97     100     96     95     388  
Austria     41     35     35     40     151  
Belgium     55     61     59     53     228  
Brazil     292     275     270     288     1125  
Bulgaria     111     122     125     112     470  
Canada     349     379     373     347     1448  
Chile     95     85     82     90     352  
China     510     492     500     515     2017  
Croatia     114     145     144     114     517  
Czech Republic     257     275     277     258     1067  
Estonia     1     0     0     1     2  
Finland     132     127     127     132     518  
France     177     163     165     175     680  
Germany     471     450     453     470     1844  
Greece     20     21     23     21     85  
India     658     650     645     646     2599  
Ireland     24     13     15     23     75  
Israel     286     272     275     282     1115  
Italy     232     260     258     231     981  
Korea, Republic of     161     149     152     165     627  
Latvia     16     16     15     15     62  
Lithuania     26     31     30     28     115  
Malaysia     29     39     39     28     135  
Mexico     16     17     19     17     69  
Netherlands     46     48     48     46     188  
New Zealand     36     31     29     29     125  
Poland     365     322     325     362     1374  
Romania     47     30     33     48     158  
Russian Federation     132     137     138     131     538  
Singapore     10     13     15     10     48  
Slovakia     93     84     83     92     352  
South Africa     24     14     14     23     75  
Spain     264     276     283     263     1086  
Sweden     10     11     9     10     40  
Switzerland     51     64     64     48     227  
Turkey     79     96     94     78     347  
United Kingdom     28     29     34     28     119  
United States     775     763     759     765     3062  
Qualifying condition  
[units: participants]
 		         
Suspected Unstable Angina (UA)     1809     1771     1757     1877     7214  
Suspected MI without ST elevation (NSTEMI)     2662     2662     2668     2539     10531  
MI with ST elevation (STEMI)     1839     1817     1839     1832     7327  
Missing     2     4     3     5     14  
Intended PCI performed [1]
[units: participants]
 		         
Yes     4377     4326     4262     4298     17263  
No     1935     1928     2005     1955     7823  
[1] The intent to perform a PCI as early as possible and no later than 72 hours of randomization was part of the criteria for inclusion



  Outcome Measures
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1.  Primary:   First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison   [ Time Frame: 30 days ]
  Show Outcome Measure 1

2.  Primary:   First Occurrence of CV Death / MI / Stroke - ASA Dose Comparison   [ Time Frame: 30 days ]
  Show Outcome Measure 2

3.  Primary:   First Occurrence of CV Death / MI / Stroke - Interaction Clopidogrel Treatment Regimen and ASA Dose Level   [ Time Frame: 30 days ]
  Show Outcome Measure 3

4.  Primary:   First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison in PCI Subgroup   [ Time Frame: 30 days ]
  Show Outcome Measure 4

5.  Secondary:   Occurrence of Major Bleeding - Clopidogrel Dose Regimen Comparison   [ Time Frame: 30 days ]
  Show Outcome Measure 5

6.  Secondary:   Occurrence of Major Bleeding - ASA Dose Level Comparison   [ Time Frame: 30 days ]
  Show Outcome Measure 6

7.  Post-Hoc:   Occurrence of Stent Thrombosis - Clopidogrel Treatment Regimen Comparison   [ Time Frame: 30 days ]
  Show Outcome Measure 7


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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